# K984600: Metra PS Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Inlet Medical, Inc.
- Decided: Jun 3, 1999 after 157 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K980123 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980123: Carter-Thomason Needle-Point Suture Passer Instrument Set, Louisville Laboratories, Inc. (1998) Summary page 1.

## Indications for use
This procedure kit is intended to facilitate passage of suture through the soft tissues of the body during laparoscopic surgery. It is to be used only by surgeons trained in laparoscopic surgery.

Source page: https://510kreport.com/device/K984600
Methodology: https://510kreport.com/methodology