510(k) K212323 ยท PKL Hemostatic Metal Clip For The Gi Tract
Instinct Plus Endoscopic Clipping Device
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Aug 25, 2021 |
| Received | Jul 26, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2026 | Wilson-Cook Medical Inc. Instinct Plus Endoscopic Clipping Device
REF: G58010
Rx Only, Sterile EO Open, Classified |
PKL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.