# K123034: Vital Sutures Suturex Cirugia Peruana Sutumed

- Pathway: 510(k) (Traditional)
- Applicant: Unilene Sac
- Decided: May 28, 2013 after 242 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K220980: Tissue Approximation System (TAS) (2023), 1 descendant of its own
- K261484: Tissue Approximation System (2026), 0 descendants of its own

## Indications for use
The nonabsorbable sutures (Monofilament Nylon, Polypropylene and Silk) are indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K123034
Methodology: https://510kreport.com/methodology