# K230480: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)

- Pathway: 510(k) (Special)
- Applicant: Teleflex Medical
- Decided: Apr 28, 2023 after 65 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- 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 K021808 (2002). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152081: Weck Auto Endo5 Hem-o-lok Ligating Clip Applier, Teleflexmedical, Inc. (2015) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok 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 structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

Source page: https://510kreport.com/device/K230480
Methodology: https://510kreport.com/methodology