# K903029: Sterile Black Monofilament Nylon Non-Absor. Suture

- Pathway: 510(k) (Traditional)
- Applicant: Look, Inc.
- Decided: Oct 25, 1990 after 107 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 30, 2011 · Not classified · Z-2138-2011: Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture.

Source page: https://510kreport.com/device/K903029
Methodology: https://510kreport.com/methodology