# K192697: Instinct Plus Endoscopic Clipping Device

- Pathway: 510(k) (Traditional)
- Applicant: Cook Endoscopy
- Decided: Mar 5, 2020 after 161 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963160 (1997). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151802: Resolution Clip, Boston Scientific Corporation (2015) Summary page 4.
- K132809: Instinct Endoscopic Hemoclip, Wilson-Cook Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K212323: Instinct Plus Endoscopic Clipping Device (2021), 0 descendants of its own

## 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 20mm 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/K192697
Methodology: https://510kreport.com/methodology