# K232313: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

- Pathway: 510(k) (Special)
- Applicant: Ethicon Endo Surgery, LLC
- Decided: Aug 29, 2023 after 27 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: 2 generations back to K864102 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150840: Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier, Ethicon Endo-Surgery, LLC (2015) Summary page 4.

## Cited in the summary but kept off the family tree
- K081488: Powder Free Latex Examination Gloves, Non-Sterile, Pt. Maja Agung Latexindo (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The LIGACLIP Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.

Source page: https://510kreport.com/device/K232313
Methodology: https://510kreport.com/methodology