# K212323: Instinct Plus Endoscopic Clipping Device

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Aug 25, 2021 after 30 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K963160 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192697: Instinct Plus Endoscopic Clipping Device, Cook Endoscopy (2020) Summary page 4.

## Recalls of this device
- Mar 3, 2026 · Class II · Z-1812-2026: Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

## Indications for use
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking, 2. Hemostasis for * Mucosal/submucosal defects less than 3 cm, * Bleeding ulcers, * Arteries less than 2 mm, * Polyps less than 1.5 cm in diameter, * Diverticula in the colon, and * Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection, 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4. As a supplementary method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively, 5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

Source page: https://510kreport.com/device/K212323
Methodology: https://510kreport.com/methodology