FDA device listing
Endoscopic Injection Needle, Gastroenterology-Urology
FDA device listing 1531963478 · BIOTEQUE CORP
Key facts
| Owner/operator | BIOTEQUE CORP |
|---|---|
| Owner/operator number | 9038266 |
| Premarket submissions | K241523 |
| Product codes | FBK |
| Device names | FBK - Endoscopic Injection Needle, Gastroenterology-Urology |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | BIOTEQUE CORP., Bioteque Corporation Yilan Science Park Factory |
| Establishment registrations | 3012480535, 3035451914 |
| FEI numbers | 3012480535, 3035451914 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter |
| 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