# K152081: Weck Auto Endo5 Hem-o-lok Ligating Clip Applier

- Pathway: 510(k) (Special)
- Applicant: Teleflexmedical, Inc.
- Decided: Aug 26, 2015 after 30 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- 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 K021808 (2002). 2 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K142777: Weck Hem-o-lok Auto Endo5 Ligating Clip Applier, Teleflexmedical, Inc. (2014) Summary page 5.

## Most influential descendants
- K230480: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (2023), 2 descendants of its own
- K254231: Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips (2026), 0 descendants of its own
- K250643: Disposable Polymer Ligation Clips (2025), 0 descendants of its own
- K161758: Weck Auto Endo10 Automatic Endoscopic Clip Applier (2016), 0 descendants of its own

## Recalls of this device
- Oct 5, 2017 · Class II · Z-0083-2018: The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.

## Indications for use
Weck Auto Endo5 Hem-o-Jok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-Jok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.

Source page: https://510kreport.com/device/K152081
Methodology: https://510kreport.com/methodology