# K981645: Titanium Hemostatic Clip

- Pathway: 510(k) (Traditional)
- Applicant: Vitalitec Int'L., Inc.
- Decided: Oct 13, 1998 after 158 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 K771021 (1977). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972745: Titanium Hemostatic Clip, Eisner USA, Inc. (1997) Summary page 1.
- K953258: Titanium Hemostatic Clip, Intramed Laboratories, Inc. (1996) Summary page 1.
- K800079: Hemoclip Surgical Occluding Clip, Edward Weck, Inc. (1980) Summary page 1.
- K853650: Auto Suture Titanium Hemostatic Clip, United States Surgical, A Division of Tyco Healthc (1985) Summary page 1.
- K771021: Auto-Clip, Axiom Medical, Inc. (1977) Summary page 1.

## Most influential descendants
- K242541: Gem Zipclip (2025), 0 descendants of its own
- K192711: Dannik Titanium Ligation Clip (2019), 0 descendants of its own
- K040602: Sureline Laparoscopic Clip Applier with Implantable Titanium Clips (2004), 0 descendants of its own

## Indications for use
The VITALITEC INTERNATIONAL, INC,. Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occclusion of vessels and prevent any slippage once applied. The clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary. Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The VITALITEC INTERNATIONAL, INC., clip can be left in vivo without sequela as it is biologically inert.

Source page: https://510kreport.com/device/K981645
Methodology: https://510kreport.com/methodology