FDA device listing
BougieCap,BougieCap P,BougieCap Set
FDA device listing 1031678692 · Ovesco Endoscopy
Key facts
| Proprietary names | BougieCap,BougieCap P,BougieCap Set |
|---|---|
| Owner/operator | Ovesco Endoscopy |
| Owner/operator number | 10031680 |
| Product codes | KNQ |
| Device names | KNQ - Dilator, Esophageal |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5365 |
| 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
- None listed 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