# K013889: Endoscopic Multi-Fire Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: Inscope, LLC
- Decided: Feb 7, 2002 after 76 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: 1 generation back to K963160 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963160: HX-5/6-1 Endoscopic Clipping Device, Olympus America, Inc. (1997) Summary page 1.

## Indications for use
The Endoscopic Multi-fire Clip Applier was designed to be used with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis of mucosal and submucosal defects < 3 cm, bleeding ulcers, arteries <2 mm, polyps < 1.5 cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. The device is not intended for repair of gastrointestinal tract lumenal perforations.

Source page: https://510kreport.com/device/K013889
Methodology: https://510kreport.com/methodology