# K100242: Auto Suture Endo Clip III5MM Clip Adapter

- Pathway: 510(k) (Special)
- Applicant: Surgical Devices, A Division of Tyco Healthcare
- Decided: Feb 17, 2010 after 21 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: 3 generations back to K883018 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071406: Autosuture Endo Clip Iii 5 MM Clip Applier, United States Surgical, A Division of Tyco Healthc (2007) Summary page 1.
- K061288: Auto Suture Endo Clip Iii 5 MM Clip Applier, United States Surgical, A Division of Tyco Healthc (2006) Summary page 1.
- K883018: Auto Suture Disp. Endoscopic Surg. Clip Applier, United States Surgical, A Division of Tyco Healthc (1988). Our reading of the summary gave K883016, FDA’s number for Polysafe Implant. Pacing Leads W/Tined Fixa. Tip (Cardiac Control Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Auto Suture Disposable Clip Applier”.

## Indications for use
The Auto Suture ENDO CLIP III 5mm Clip Applier is primarily indicated for patients undergoing laproscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.

Source page: https://510kreport.com/device/K100242
Methodology: https://510kreport.com/methodology