--- title: "Urology Devices, Definition | MedTech Terms" description: "Devices for diagnosis and treatment of disorders of the urinary tract and male reproductive system, including BPH therapy, stone management, and continence…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/urology-devices#term", "name": "Urology Devices", "description": "The urology MedTech segment includes BPH (benign prostatic hyperplasia) therapies (laser enucleation, water-vapor, prostatic urethral lift), kidney-stone management (lithotripsy, ureteroscopes, baskets), incontinence and pelvic-floor devices (slings, artificial urinary sphincters, sacral neuromodulation), urodynamics systems, and erectile prosthetics. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Urology Devices [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Urology Devices Devices for diagnosis and treatment of disorders of the urinary tract and male reproductive system, including BPH therapy, stone management, and continence devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## Definition The urology MedTech segment includes BPH (benign prostatic hyperplasia) therapies (laser enucleation, water-vapor, prostatic urethral lift), kidney-stone management (lithotripsy, ureteroscopes, baskets), incontinence and pelvic-floor devices (slings, artificial urinary sphincters, sacral [neuromodulation](/terms/neuromodulation)), urodynamics systems, and erectile prosthetics. Class spans Class I catheters through Class III implants. What the regulation says Most urology devices are regulated under 21 CFR 876. Sacral neuromodulators are [PMA](/terms/pma) Class III. Energy-based BPH devices typically clear via 510(k) with comparative clinical data in expanded submissions. ## What this means in practice Reimbursement turns on AUA guideline alignment and CMS coverage for the specific procedure code. Outpatient migration ( [ASC site-of-service shift](/terms/asc-shift)) is a major economic driver. Common pitfalls - • Assuming a slight energy-modality change qualifies as substantially equivalent without comparative clinical data. - • Overlooking the AUA practice guidelines that drive payer coverage decisions. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Neuromodulation Implantable devices that stimulate the nervous system to treat disease. ](/terms/neuromodulation)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Reimbursement ASC Site-of-Service Shift Migration of procedures from hospitals to ambulatory surgery centers. ](/terms/asc-shift)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma) ### 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 eCFR· 1 AUA· 1 AdvaMed· 1 1. [1 21 CFR 876 Gastroenterology-Urology Devices Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876) 2. [2 American Urological Association Guidelines Verified AUA · auanet.org ](https://www.auanet.org/guidelines-and-quality) 3. [3 AdvaMed - Industry Reports Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) 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=urology-devices) Learn in 60 seconds Card Lesson Quiz Devices for diagnosis and treatment of disorders of the urinary tract and male reproductive system, including BPH therapy, stone management, and continence devices. - · Reimbursement turns on AUA guideline alignment and CMS coverage for the specific procedure code. - · Outpatient migration (ASC site-of-service shift) is a major economic driver. - · Class spans Class I catheters through Class III implants. Remember this Watch out: Assuming a slight energy-modality change qualifies as substantially equivalent without comparative clinical data. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Premarket Approval(PMA) ](/terms/pma) - [Neuromodulation ](/terms/neuromodulation) - [ASC Site-of-Service Shift ](/terms/asc-shift) You may also need Auto-suggested from Market Segments and shared keywords. - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [Endoscopy Devices ](/terms/endoscopy-devices) - [Ophthalmology Devices ](/terms/ophthalmology-devices) - [Women's Health Devices ](/terms/womens-health) - [Dental Devices ](/terms/dental-devices) - [In Vitro Diagnostics (Segment)(IVD) ](/terms/ivd-segment) [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. 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