# K972745: Titanium Hemostatic Clip

- Pathway: 510(k) (Traditional)
- Applicant: Eisner USA, Inc.
- Decided: Oct 21, 1997 after 90 days
- Product code: MCH (Clip, Hemostatic)
- 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: 1 generation back to K771021 (1977). 4 ancestors in all.
4 later devices descend from it; 1 cites 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)
- 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.
- (no number) Edward Weck & Company, Pre-amendment Hemoclip® Surgical Occluding System: named in the summary without a submission number

## Most influential descendants
- K981645: Titanium Hemostatic Clip (1998), 3 descendants of its own
- 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 EISNER USA Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occlusion 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. As the clip is made of Commercially Pure - GRADE I, Implant Titanium (ASTM Standard F-67 95), it has low magnetic susceptibility and is safe for use in the present clinical MRI environment with main Magnetic fields up to 2 Telsa and maximum main field-gradients up to 500 gauss per centimeter. The Magnetic Force will only approach gravitational force for MR Systems above 15 T. As the clip is made of Commercially Pure - GRADE I, Implant Titanium (ASTM Standard F-67-95), it also produces less artifact and better resolution of anatomic structures than non-titanium clips in CT Scanning. (Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The EISNER USA Clip can be left in vivo without sequela as it is biologically inert.)

Source page: https://510kreport.com/device/K972745
Methodology: https://510kreport.com/methodology