# K830503: Ligaclip Titanium Ligating Clip

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 8, 1983 after 20 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050344: Ligaclip 5 M/L MM Endoscopic Multiple Clip Applier (2005), 3 descendants of its own
- K032238: Twister Superelastic Ligating Clip and Applier (2003), 3 descendants of its own
- K140932: Amsel Occluder Device (2015), 2 descendants of its own
- K110699: Ligamax 5 (2011), 1 descendant of its own
- K100090: Implantable Clip (2010), 1 descendant of its own

## Recalls of this device
- Apr 12, 2013 · Class II · Z-1775-2013: Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in im
- Apr 12, 2013 · Class II · Z-1777-2013: Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in im
- Apr 12, 2013 · Class II · Z-1776-2013: Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in im

Source page: https://510kreport.com/device/K830503
Methodology: https://510kreport.com/methodology