# K053585: Vanguard Reprocessed Suture Passer

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Oct 11, 2006 after 292 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 11, 2008 · Not classified · Z-1674-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

## Indications for use
Reprocessed Suture Passers are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.

Source page: https://510kreport.com/device/K053585
Methodology: https://510kreport.com/methodology