# K143644: Premium Surgiclip¿; Endo Clip¿; AcuClip¿

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Sep 14, 2015 after 266 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 K883018 (1988). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853650: Auto Suture Titanium Hemostatic Clip, United States Surgical, A Division of Tyco Healthc (1985) Summary page 6.
- K142869: Premium Surgiclip III, Covidien (2014) Summary page 6.
- K061288: Auto Suture Endo Clip Iii 5 MM Clip Applier, United States Surgical, A Division of Tyco Healthc (2006) Summary page 6.
- K883018: Auto Suture Disp. Endoscopic Surg. Clip Applier, United States Surgical, A Division of Tyco Healthc (1988) Summary page 6.
- K920599: Hook Surgical Instrument, Origin Medsystems, Inc. (1992) Summary page 6.

## Most influential descendants
- K221495: SOLID CLIP™ Single Use Clip Applier (2024), 0 descendants of its own

## Indications for use
The Premium Surgiclip™ clip applier has application in many types of surgical procedures to occlude vessels and other tubular structures and for vagotomy. sympathectomy and radiographic markings Endo Clip™ M, ML, L - The Endo Clip™ clip applier has application in endoscopic procedures to achieve occlusion of vessels and other tubular structures. and for radiographic markings. Endo Clip™ 5mm - The Endo Clip™ clip applier has applications in endoscopic procedures to achieve occlusion of vessels and other tubular structures and for radiographic markings. Endo Clip™ II - The Endo Clip™ II clip applier has application in many types of endoscopic procedures to achieve occlusion of vessels and other tubular structures and for radiographic markings. The instrument is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures. It can also be used to mark anatomical structures during surgery, and for radiographic marking.

Source page: https://510kreport.com/device/K143644
Methodology: https://510kreport.com/methodology