# K123601: Single Use Repositionable Clip

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Apr 29, 2013 after 159 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: 4 (0 Class I)
- 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)
- K013066: HX-5/6-1 Endoscopic Clipping Device, Olympus America, Inc. (2001) Summary page 2.

## Most influential descendants
- K183021: ClearEndoclip (2019), 2 descendants of its own
- K213338: Core-Clip (2022), 0 descendants of its own
- K200217: ClearEndoclip (2020), 0 descendants of its own

## Recalls of this device
- May 4, 2023 · Class II · Z-1990-2023: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms
- May 4, 2023 · Class II · Z-1987-2023: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms
- May 4, 2023 · Class II · Z-1988-2023: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms
- May 4, 2023 · Class II · Z-1989-2023: Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms

## Indications for use
This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (Gl) tract. It is indicated to be used for (1) endoscopic marking (2) hemostasis for (a) mucosal/sub-mucosal defects < 3 cm, (b) bleeding ulcers, (c) arteries <2 mm, (d) polyps < 1.5 cm in diameter, (e) diverticula in the colon, (3) anchoring to affix jejunal feeding tubes to the wall of the small bowel, (4) as a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treated conservatively.

Source page: https://510kreport.com/device/K123601
Methodology: https://510kreport.com/methodology