FDA device listing
Rigid and Flexible Endoscopes
FDA device listing 1583641437 · Marina Medical Instruments
Key facts
| Proprietary names | Rigid and Flexible Endoscopes |
|---|---|
| Owner/operator | Marina Medical Instruments |
| Owner/operator number | 9001093 |
| Premarket submissions | K993689 |
| Product codes | FAJ |
| Device names | FAJ - Cystoscope And Accessories, Flexible/Rigid |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | MARINA MEDICAL INSTRUMENTS, INC. |
| Establishment registrations | 2084346 |
| FEI numbers | 1000124817 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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