Instinct Plus Endoscopic Clipping Device
FDA 510(k) clearance K212323 · decided 2021-08-25
Clearance details
- K-number
- K212323
- Device name
- Instinct Plus Endoscopic Clipping Device
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-26
- Decision date
- 2021-08-25
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- PKL
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Wilson-Cook Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO recall (Z-1812-2026) | Wilson-Cook Medical Inc. | 2026-04-13 |