# K023903: Wilson-Cook Endoscopic Clipping Device

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Feb 20, 2003 after 90 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: 2 generations back to K963160 (1997). 2 ancestors in all.
4 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)
- K990687: HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips, Olympus Optical, Co. (1999) Summary page 1.

## Most influential descendants
- K121505: Disposable Hemostasis Chip (2012), 3 descendants of its own
- 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

## Recalls of this device
- Jun 7, 2011 · Not classified · Z-2691-2011: The disposable clip may not deploy after being positioned inside the patient.

## Indications for use
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 Gl tract lumenal perforations.

Source page: https://510kreport.com/device/K023903
Methodology: https://510kreport.com/methodology