# K030269: Genicon Clip Applier

- Pathway: 510(k) (Traditional)
- Applicant: Genicon, LC
- Decided: Mar 20, 2003 after 52 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- 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 its predicate without a number.
- (no number) United States Surgical Corporation: named in the summary without a submission number

## Recalls of this device
- Sep 17, 2020 · Class II · Z-0310-2021: Device malfunction causing the applier to jam, and clip loading failures.

## Indications for use
The GeniCon Clip Applier and implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.

Source page: https://510kreport.com/device/K030269
Methodology: https://510kreport.com/methodology