--- title: "Endoscopy Devices, Definition | MedTech Terms" description: "Flexible and rigid scopes plus accessories used for visualization, diagnosis, and therapy inside the GI tract, airways, urinary tract, and joints." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/endoscopy-devices#term", "name": "Endoscopy Devices", "alternateName": [ "GI endoscopy", "Flexible endoscopy" ], "description": "The endoscopy segment covers flexible video gastroscopes, colonoscopes, duodenoscopes, bronchoscopes, ureteroscopes, and rigid arthroscopes, together with the light sources, processors, capnography, insufflators, and single-use accessories (snares, biopsy forceps, hemoclips) that complete a procedure. The market splits between reusable scopes (capital + reprocessing) and a fast-growing single-use segment driven by infection-control concerns following duodenoscope-associated CRE outbreaks (FDA 2015-2019 safety communications).", "url": "https://medtechterms.com/terms/endoscopy-devices", "termCode": "endoscopy-devices", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/endoscopy-devices#article", "headline": "Endoscopy Devices", "description": "Flexible and rigid scopes plus accessories used for visualization, diagnosis, and therapy inside the GI tract, airways, urinary tract, and joints.", "url": "https://medtechterms.com/terms/endoscopy-devices", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/endoscopy-devices" }, "about": { "@id": "https://medtechterms.com/terms/endoscopy-devices#term" }, "articleSection": "Market Segments", "inLanguage": "en", "keywords": "Endoscopy Devices, GI endoscopy, Flexible endoscopy, Market Segments, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-09", "dateModified": "2026-05-09", "citation": [ { "@type": "CreativeWork", "name": "FDA, Duodenoscope Reprocessing", "url": "https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "21 CFR 876 Gastroenterology-Urology Devices", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876", "publisher": { "@type": "Organization", "name": "eCFR" } }, { "@type": "CreativeWork", "name": "MedTech Dive", "url": "https://www.medtechdive.com/", "publisher": { "@type": "Organization", "name": "MedTech Dive" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/samd#term", "name": "Software as a Medical Device", "alternateName": "SaMD", "url": "https://medtechterms.com/terms/samd" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/post-market-surveillance#term", "name": "Post-Market Surveillance", "alternateName": "PMS", "url": "https://medtechterms.com/terms/post-market-surveillance" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/single-use-device#term", "name": "Single-Use Device", "alternateName": "SUD", "url": "https://medtechterms.com/terms/single-use-device" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Market Segments", "item": "https://medtechterms.com/terms?cat=Market%20Segments" }, { "@type": "ListItem", "position": 4, "name": "Endoscopy Devices", "item": "https://medtechterms.com/terms/endoscopy-devices" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/endoscopy-devices#faq", "mainEntity": [ { "@type": "Question", "name": "Why did FDA push duodenoscope makers toward single-use designs?", "acceptedAnswer": { "@type": "Answer", "text": "Repeated CRE and other multidrug-resistant infection outbreaks tied to incomplete reprocessing of the elevator mechanism led FDA to recommend transition to disposable-component or fully single-use designs in 2019." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Endoscopy Devices [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Endoscopy Devices Flexible and rigid scopes plus accessories used for visualization, diagnosis, and therapy inside the GI tract, airways, urinary tract, and joints. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## Definition The endoscopy segment covers flexible video gastroscopes, colonoscopes, duodenoscopes, bronchoscopes, ureteroscopes, and rigid arthroscopes, together with the light sources, processors, capnography, insufflators, and single-use accessories (snares, biopsy forceps, hemoclips) that complete a procedure. The market splits between reusable scopes (capital + reprocessing) and a fast-growing single-use segment driven by infection-control concerns following duodenoscope-associated CRE outbreaks (FDA 2015-2019 safety communications). What the regulation says Most flexible endoscopes are Class II 510(k) devices under 21 CFR 876 (gastroenterology-urology) or 874 (ENT). FDA's reprocessing guidance and the duodenoscope safety communications materially changed expectations for reprocessing validation, single-use components (caps, elevators), and [post-market surveillance](/terms/post-market-surveillance) studies (522 orders). ## What this means in practice Single-use scopes (Ambu, Boston Scientific Exalt) and disposable elevator caps reset the segment's economics. AI-assisted polyp detection (CADe) is now a major sub-segment with multiple FDA-cleared products (e.g., GI Genius, Endoscreener). Common pitfalls - • Underestimating reprocessing validation requirements, FDA expects multi-cycle worst-case soiling validation. - • Treating an AI overlay as a feature rather than a separate SaMD requiring its own clearance. - • Ignoring FDA 522 post-market surveillance orders applicable to duodenoscopes. ## Frequently asked questions Why did FDA push duodenoscope makers toward single-use designs? Repeated CRE and other multidrug-resistant infection outbreaks tied to incomplete reprocessing of the elevator mechanism led FDA to recommend transition to disposable-component or fully single-use designs in 2019. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Single-Use Device(SUD) A device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs. ](/terms/single-use-device)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance)[ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 eCFR· 1 MedTech Dive· 1 1. [1 FDA, Duodenoscope Reprocessing Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes) 2. [2 21 CFR 876 Gastroenterology-Urology Devices Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876) 3. [3 MedTech Dive Verified MedTech Dive · medtechdive.com ](https://www.medtechdive.com/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Sources 3 Updated 5/9/2026 [Compare with another term](/compare?a=endoscopy-devices) Learn in 60 seconds Card Lesson Quiz Flexible and rigid scopes plus accessories used for visualization, diagnosis, and therapy inside the GI tract, airways, urinary tract, and joints. - · Single-use scopes (Ambu, Boston Scientific Exalt) and disposable elevator caps reset the segment's economics. - · AI-assisted polyp detection (CADe) is now a major sub-segment with multiple FDA-cleared products (e.g., GI Genius, Endoscreener). Remember this Watch out: Underestimating reprocessing validation requirements, FDA expects multi-cycle worst-case soiling validation. Related terms - [Software as a Medical Device(SaMD) ](/terms/samd) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) - [Single-Use Device(SUD) ](/terms/single-use-device) You may also need Auto-suggested from Market Segments and shared keywords. - [Urology Devices ](/terms/urology-devices) - [Patient Monitoring ](/terms/patient-monitoring) - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [Hearing Devices ](/terms/hearing-devices) - [Sleep & Respiratory Devices ](/terms/sleep-respiratory-devices) - [Digital Therapeutic(DTx) ](/terms/samd-dtx) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)