FDA device listing
Digital Cystoscope,Digital Cystoscope Disposal Sheaths 1.5mm,Digital Cystoscope Disposal Sheaths 2.1mm,EndoSheath for…
FDA device listing 1054371883 · STRYKER CORP.
Key facts
| Proprietary names | Digital Cystoscope,Digital Cystoscope Disposal Sheaths 1.5mm,Digital Cystoscope Disposal Sheaths 2.1mm,EndoSheath for Digital Cystoscope |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K072180 |
| Product codes | FAJ, FED, FFS |
| Device names | FAJ - Cystoscope And Accessories, Flexible/Rigid, FED - Endoscopic Access Overtube, Gastroenterology-Urology, FFS - Image, Illumination, Fiberoptic, For Endoscope |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | STRYKER EMEA Supply Chain Services, STRYKER ENDOSCOPY |
| Establishment registrations | 2936485, 3008837339 |
| FEI numbers | 2936485, 3008837339 |
| Establishment operations | Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database