# K043330: Polypropilene Surgical Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Demetech Corp.
- Decided: May 16, 2005 after 165 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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 K001625 (2000). 1 ancestor in all.
1 later device descends 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)
- K001625: Pronova Nonabsorbable Suture, Usp, ETHICON, Inc. (2000) Summary page 1.

## Most influential descendants
- K103704: Remotely Controlled Mandibular Positioner, RCMP (2012), 0 descendants of its own

## Indications for use
The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures.

Source page: https://510kreport.com/device/K043330
Methodology: https://510kreport.com/methodology