# K962480: Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Aug 2, 1996 after 37 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
76 later devices descend from it; 4 cite it directly.
0 of 77 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 RAPIDE (polyglactin 910) braided synthetic absorbable suture, undyed: 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
- Apr 20, 2010 · Not classified · Z-1608-2010: Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during t
- Aug 11, 2008 · Not classified · Z-0021-2009: Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.

## Indications for use
6-0 undyed Coated VICRYL RAPIDE suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL RAPIDE suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K962480
Methodology: https://510kreport.com/methodology