# K944110: Vicryl Rapide Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jan 18, 1995 after 148 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.
72 later devices descend from it; 11 cite it directly.
0 of 73 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 suture: named in the summary without a submission number
- (no number) ETHICON surgical (plain) gut suture: named in the summary without a submission number

## Most influential descendants
- K013671: L-25 Absorbable Surigcal Suture (2002), 43 descendants of its own
- K040477: Monoderm (2004), 29 descendants of its own
- K052437: Modified Monoderm Monofilament, Synthetic, Absorbable Suture (2005), 28 descendants of its own
- K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm (2007), 26 descendants of its own
- K100257: VLOC9ABSORBABLE Wound Closure Device (2010), 24 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
VICRYL rapide suture is intended for use in soft tissue approximation, (i.e., mucosa and skin), where only short term wound support. is required and where the rapid absorption of the suture would be beneficial.

Source page: https://510kreport.com/device/K944110
Methodology: https://510kreport.com/methodology