Identifiers
- 510(k) Number
- K043021 FDA 510(k)
- FDA Product Code
- FGB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A ureteroscope is an endoscope used for visualization of the urinary tract. This device is a flexible or rigid ureteroscope and accessories as classified under device name Ureteroscope And Accessories, Flexible/Rigid.
It is supplied non-sterile and intended for reuse after appropriate cleaning and sterilization. The device is regulated as a Class II medical device under FDA 510(k) clearance K043021, with product code FGB and regulation number 876.1500.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Semi-rigid autoclavable ureteroscope - Stryker, Ureteroscope endoscope / semi-flexible SRU-6, SRU-6x S Stryker, STRYKER VIDEO URETEROSCOPE (K121112) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043021 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K043021 24 fields · synced Sep 25, 2026