# K030311: Hem-O-Lok XL Clip

- Pathway: 510(k) (Special)
- Applicant: Weck
- Decided: Feb 26, 2003 after 27 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
No predicates in its family tree.
26 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) previously cleared Weck Hem-o-lok clip sizes: named in the summary without a submission number

## Most influential descendants
- K093679: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide  Model Various LAA0 (2010), 18 descendants of its own
- K122276: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip (2012), 15 descendants of its own
- K153500: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip (2016), 10 descendants of its own
- K173031: AtriClip LAA Exclusion System with Preloaded PRO·V Clip (2017), 9 descendants of its own
- K180010: AtriClip FLEX-V (2018), 8 descendants of its own

## Recalls of this device
- Apr 12, 2006 · Not classified · Z-1098-06: The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the 

## Indications for use
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 such that the clip completely encompasses the vessel or tissue structure.

Source page: https://510kreport.com/device/K030311
Methodology: https://510kreport.com/methodology