FDA device listing
colonic FTRD Set,diagnostic FTRD Set,FTRD System Set
FDA device listing 1422852725 · Ovesco Endoscopy
Key facts
| Proprietary names | colonic FTRD Set,diagnostic FTRD Set,FTRD System Set |
|---|---|
| Owner/operator | Ovesco Endoscopy |
| Owner/operator number | 10031680 |
| Premarket submissions | K170867 |
| Product codes | FDI, KNS, OCZ, PKL |
| Device names | FDI - Snare, Flexible, KNS - Unit, Electrosurgical, Endoscopic (With Or Without Accessories), OCZ - Endoscopic Grasping/Cutting Instrument, Non-Powered, PKL - Hemostatic Metal Clip For The Gi Tract |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 876.4300, 876.4400 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | OVESCO ENDOSCOPY AG, Ovesco Endoscopy USA |
| Establishment registrations | 3006696607, 3008720584 |
| FEI numbers | 3006696607, 3008720584 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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