Identifiers
- 510(k) Number
- K121112 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 and accessories, flexible/rigid, is a flexible endoscope featuring a distal-tip video sensor and integrated light fibers. It is used for visualization and diagnostic/therapeutic procedures in the urethra, bladder, ureter, and kidney.
The device is supplied as a reusable endoscope and is intended for use in endoscopic procedures. It received FDA 510(k) clearance under K121112 with product code FGB and regulation number 876.1500, and is classified as a Class II medical device.
Frequently asked questions
What is the STRYKER VIDEO URETEROSCOPE used for?
It is used for visualization and diagnostic or therapeutic procedures in the urethra, bladder, ureter, and kidney, enabling clinicians to view internal urinary tract structures during endoscopic interventions.
Is the STRYKER VIDEO URETEROSCOPE reusable or single-use?
The device is supplied as a reusable endoscope, meaning it is designed for multiple uses after proper cleaning, disinfection, and sterilization in accordance with the manufacturer’s instructions for reuse.
What type of imaging and illumination does the STRYKER VIDEO URETEROSCOPE feature?
It features a distal-tip video sensor and integrated light fibers, providing direct video visualization and illumination at the tip of the scope for real-time viewing during procedures.
What regulatory pathway was used for the STRYKER VIDEO URETEROSCOPE?
It received FDA 510(k) clearance under submission K121112, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under product code FGB.
What are the key identifiers for the STRYKER VIDEO URETEROSCOPE in regulatory databases?
The device is identified by the name STRYKER VIDEO URETEROSCOPE, product code FGB, regulation number 876.1500, and FDA 510(k) number K121112, with classification as a Class II ureteroscope and accessories, flexible/rigid.
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: STRYKER VIDEO URETEROSCOPE (K121112) — FDA 510(k) | Innolitics, Endoscopy | Stryker, Introducing Stryker's F88 flexible ureteroscope - YouTube, STRYKER VIDEO URETEROSCOPE 510 (k) K121112 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121112 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K121112 24 fields · synced Sep 25, 2026