# K022269: Coated Vicryl* (Polyglactin 910) Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Sep 13, 2002 after 60 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
108 later devices descend from it; 11 cite it directly.
0 of 109 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
- K024117: Insorb Absorbable Staples, Model SP-B20 (2003), 68 descendants of its own
- K051609: Quill Synthetic Absorbable Barbed Suture (2005), 64 descendants of its own
- K071989: Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material (2007), 31 descendants of its own
- K080680: Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone (2008), 30 descendants of its own
- K080985: Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) (2008), 29 descendants of its own

## Recalls of this device
- May 10, 2024 · Class II · Z-2144-2024: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Jan 3, 2020 · Class II · Z-0989-2020: Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
- May 4, 2006 · Not classified · Z-1087-06: Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.

## Indications for use
Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Source page: https://510kreport.com/device/K022269
Methodology: https://510kreport.com/methodology