# K121505: Disposable Hemostasis Chip

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
- Decided: Aug 31, 2012 after 102 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: 3 generations back to K963160 (1997). 3 ancestors in all.
3 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)
- K023903: Wilson-Cook Endoscopic Clipping Device, Wilson-Cook Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K132809: Instinct Endoscopic Hemoclip (2013), 2 descendants of its own
- 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/K121505
Methodology: https://510kreport.com/methodology