The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Instinct Plus Endoscopic Clipping Device.
| Device ID | K212323 |
| 510k Number | K212323 |
| Device Name: | Instinct Plus Endoscopic Clipping Device |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Scottie Fariole |
| Correspondent | Scottie Fariole Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-26 |
| Decision Date | 2021-08-25 |