# K132809: Instinct Endoscopic Hemoclip

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Oct 25, 2013 after 46 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: 4 generations back to K963160 (1997). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121505: Disposable Hemostasis Chip, Wilson-Cook Medical Inc./Cook Endoscopy (2012) Summary page 1.

## Most influential descendants
- K192697: Instinct Plus Endoscopic Clipping Device (2020), 1 descendant of its own
- 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 endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

Source page: https://510kreport.com/device/K132809
Methodology: https://510kreport.com/methodology