# K211178: DURAMESH Mesh Suture

- Pathway: 510(k) (Traditional)
- Applicant: Msi
- Decided: Sep 2, 2022 after 500 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: 12 generations back to K014153 (2002). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131224: Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill Polypropylene Knotless Tissue-Closure, Surgical Specialties Corp. Dba Angiotech (2013) Summary page 4.

## Indications for use
Duramesh™ Mesh Suture is indicated for general soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy where the bowel is not entered. Duramesh™ is not for use in the skin and other epithelial surfaces, cardiovascular, ophthalmic, and/or neurological procedures.

Source page: https://510kreport.com/device/K211178
Methodology: https://510kreport.com/methodology