# K812291: Ethicon Multiple Ligating Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Sep 11, 1981 after 29 days
- Product code: GDO (Applier, Surgical, Clip)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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/K812291
Methodology: https://510kreport.com/methodology