FDA device listing
Coaxial
FDA device listing 1900528671 · Needle Specialty Products
Key facts
| Proprietary names | Coaxial |
|---|---|
| Owner/operator | Needle Specialty Products |
| Owner/operator number | 10042203 |
| Product codes | FCG, GBX |
| Device names | FCG - Biopsy Needle, GBX - Catheter, Irrigation |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 876.1075, 878.4200 |
| Review panels | Gastroenterology & Urology, General & Plastic Surgery |
| Registered establishments | NEEDLE SPECIALTY PRODUCTS |
| Establishment registrations | 1000112137 |
| FEI numbers | 1000112137 |
| Establishment operations | Contract 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