# K953258: Titanium Hemostatic Clip

- Pathway: 510(k) (Traditional)
- Applicant: Intramed Laboratories, Inc.
- Decided: Jan 5, 1996 after 177 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972745: Titanium Hemostatic Clip (1997), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K953258
Methodology: https://510kreport.com/methodology
