# K033746: Modified Coated Vicryl* Rapide (Polyglactin 910) Suture

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Dec 18, 2003 after 17 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 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) Suture: named in the summary without a submission number

## Most influential descendants
- K120556: Vilet Vilet Quick (2012), 2 descendants of its own
- K061796: Hepatostat Set, Model 760X (2006), 1 descendant of its own
- K263073: Fast Absorbing PGLA (2026), 0 descendants of its own
- K170166: CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture (2017), 0 descendants of its own
- K123940: Demequicktm (Rapid Absorbable) Synthetic Surgical Suture (2014), 0 descendants of its own

## Recalls of this device
- Aug 17, 2017 · Class II · Z-0693-2018: On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. Durin
- 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
Modified Coated VICRYL* Rapide synthetic absorbable suture is indicated only for use in superficial 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/K033746
Methodology: https://510kreport.com/methodology