# K102081: Endoscopic Clip System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Aug 6, 2010 after 11 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962493 (1996). 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)
- K080753: Aesculap Endoscopic Clip Sytem, Aesculap, Inc. (2008) Summary page 1.

## Recalls of this device
- Jan 22, 2018 · Class II · Z-1290-2018: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation
- Jan 22, 2018 · Class II · Z-1291-2018: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.

## Indications for use
The devices presented in this submission are intended for use in endloscopic and/or open surgery for ligating and marking vessels and tubular structures whenever ligating clips are used/indicated.

Source page: https://510kreport.com/device/K102081
Methodology: https://510kreport.com/methodology