# K022715: Coated Vicryl Plus Antimicrobial (Polyglactin 910) Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 19, 2002 after 126 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture: named in the summary without a submission number

## Most influential descendants
- K072859: Atramat PGLA90 Poly (Glycolide-CO-L-Lactide) Surgical Sutures (2008), 1 descendant of its own
- K252820: PGLA90 Poly (glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly (glycolide-co-L-lactide) Surgical Sutures (Odysseus) (2025), 0 descendants of its own
- K123668: Orthocord (2013), 0 descendants of its own

## Recalls of this device
- Mar 12, 2019 · Class II · Z-1134-2019: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

## Indications for use
Modified Coated VICRYL* 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/K022715
Methodology: https://510kreport.com/methodology