FDA device listing
Osteo-Site® Bone Biopsy Needle,Osteo-Site® Bone Biopsy Needle Murphy M1M™,Osteo-Site® Bone Biopsy Needle Murphy…
FDA device listing 1566339549 · COOK, INC.
Key facts
| Proprietary names | Osteo-Site® Bone Biopsy Needle,Osteo-Site® Bone Biopsy Needle Murphy M1M™,Osteo-Site® Bone Biopsy Needle Murphy M2™,Osteo-Site® Bone Biopsy Needle Set Murphy M2™ |
|---|---|
| Owner/operator | COOK, INC. |
| Owner/operator number | 1820334 |
| Premarket submissions | K170008 |
| Product codes | KNW |
| Device names | KNW - Instrument, Biopsy |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1075 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Cook Incorporated, COOK INCORPORATED |
| Establishment registrations | 1820334, 1000393132 |
| FEI numbers | 1820334, 1000393132 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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