# K100461: PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut

- Pathway: 510(k) (Abbreviated)
- Applicant: Riverpoint Medical
- Decided: Jul 8, 2010 after 140 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960653 (1996). 9 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061037: PDS Plus Antibacterial Suture, ETHICON, Inc. (2006) Summary page 2.
- K972566: Dexon Violet, Davis & Geck, Inc. (1997) Summary page 2.
- K023710: Visorb Swift, Cp Medical (2003) Summary page 2.
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified), ETHICON, Inc. (1996) Summary page 2.

## Most influential descendants
- K130737: Synthetic Absorbable Suture (2014), 2 descendants of its own
- K142810: WEGO-PGCL Absorbable Surgical Monofilament Suture (2014), 1 descendant of its own
- K130083: Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture (2013), 1 descendant of its own
- K232372: Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (2024), 0 descendants of its own
- K173779: Rexmono, Pdrex (2018), 0 descendants of its own

## Recalls of this device
- Dec 13, 2012 · Class II · Z-0347-2014: Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.

## Indications for use
PGA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. PGA suture is provided sterile as a single use device. Vilet Quick surgical suture is indicated for use in general soft tissue approximation, including use in ophthalmic procedures, where only short-term wound support is required. Vilet Quick is not intended for use in cardiovascular or neurological procedures. Vilet Quick suture is provided sterile as a single use device. PGCL surgical suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures. PGCL suture is provided sterile as a single use device. PDO surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and/or sclera). PDO Suture is not intended for use in adult cardiovascular tissue, microsurgery or neural tissue. PDO suture is provided sterile as a single use device.

Source page: https://510kreport.com/device/K100461
Methodology: https://510kreport.com/methodology