# K253394: Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jun 25, 2026 after 268 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032420 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181652: Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture, ETHICON, Inc. (2018) Summary page 5.

## Indications for use
Coated VICRYL™ Plus Antibacterial Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

Source page: https://510kreport.com/device/K253394
Methodology: https://510kreport.com/methodology