# K133414: Reprocessed Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jan 22, 2014 after 76 days
- Product code: NLM (Laparoscope, General & Plastic Surgery, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Mar 20, 2015 · Class II · Z-1630-2015: The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry hole

## Indications for use
The reprocessed closure systems are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.

Source page: https://510kreport.com/device/K133414
Methodology: https://510kreport.com/methodology