# K192711: Dannik Titanium Ligation Clip

- Pathway: 510(k) (Traditional)
- Applicant: Dannik
- Decided: Dec 20, 2019 after 84 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 K771021 (1977). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981645: Titanium Hemostatic Clip, Vitalitec Int'L., Inc. (1998) Summary page 4.
- K132658: Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting Clips, Teleflex Medical (2013) Summary page 4.

## Indications for use
The DANNIK Titanium Ligation Clips 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. Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The DANNIK Titanium Ligation, clip can be left in vivo without sequela as it is biologically inert.

Source page: https://510kreport.com/device/K192711
Methodology: https://510kreport.com/methodology