# K161758: Weck Auto Endo10 Automatic Endoscopic Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Sep 7, 2016 after 72 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.
No later device cites it as a predicate yet.
0 of 4 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 5.

## Indications for use
Weck Auto Endo10 Hem-o-lok L automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok L non-absorbable polymer ligating clips. These appliers are designed for use with 10/11 mm 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/K161758
Methodology: https://510kreport.com/methodology