# K181652: Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Sep 28, 2018 after 98 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K032420 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132580: Coated Vicryl Plus Antimicrobial (Polyglactin 910) Synthetic Absorbable Suture, ETHICON, Inc. (2014) Summary page 4.

## Most influential descendants
- K253394: Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture (2026), 0 descendants of its own

## Recalls of this device
- May 10, 2024 · Class II · Z-2145-2024: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

## Indications for use
Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable 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/K181652
Methodology: https://510kreport.com/methodology