# K034029: TI Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: Gyrx, LLC
- Decided: Mar 5, 2004 after 67 days
- Product code: NJC (Clip, Vas Deferens)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Ti Clip Applier is indicated for ligation of the vas deferens.

Source page: https://510kreport.com/device/K034029
Methodology: https://510kreport.com/methodology