# K812323: PDS* Absorbable Ligating Clips

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Nov 16, 1981 after 91 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.
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
- Feb 28, 2005 · Not classified · Z-0657-05: The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
- Feb 28, 2005 · Not classified · Z-0654-05: The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
- Feb 28, 2005 · Not classified · Z-0655-05: The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
- Feb 28, 2005 · Not classified · Z-0656-05: The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.

Source page: https://510kreport.com/device/K812323
Methodology: https://510kreport.com/methodology