# K091574: Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures

- Pathway: 510(k) (Abbreviated)
- Applicant: Supplidores Unidos Internacionales, S.A.
- Decided: Oct 9, 2009 after 129 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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 K001184 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001184: Silk, Nonabsorbable, Surgical Sutures, Usp, Cp Medical (2000) Summary page 1.
- K001173: Nylon, Nonabsorbable Surgical Sutures Usp, Cp Medical (2000) Summary page 1.
- K001185: Polypropylene, Nonabsorbable Surgical Sutures Usp, Cp Medical (2000) Summary page 1.
- K001172: Polyester Nonabsorbable Surgical Sutures Urp, Cp Medical (2000) Summary page 1.

## Indications for use
General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures. General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures. General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures. General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

Source page: https://510kreport.com/device/K091574
Methodology: https://510kreport.com/methodology