# K864102: Ligaclip 20/20* Multiple Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Nov 5, 1986 after 15 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 5 cite it directly.
0 of 11 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
- K150840: Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier (2015), 2 descendants of its own
- K140932: Amsel Occluder Device (2015), 2 descendants of its own
- K110699: Ligamax 5 (2011), 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
- Jun 7, 2004 · Not classified · Z-1055-04: This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.

Source page: https://510kreport.com/device/K864102
Methodology: https://510kreport.com/methodology