# K120556: Vilet Vilet Quick - Pathway: 510(k) (Abbreviated) - Applicant: Riverpoint Medical - Decided: May 23, 2012 after 89 days - Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) - Device class: 2 - Regulation: 21 CFR 878.4493 - Recalls of this device: 41 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K022269 (2002). 2 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 5 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K022269: Coated Vicryl* (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 2. - K033746: Modified Coated Vicryl* Rapide (Polyglactin 910) Suture, ETHICON, Inc. (2003) ## Most influential descendants - K263073: Fast Absorbing PGLA (2026), 0 descendants of its own - K123940: Demequicktm (Rapid Absorbable) Synthetic Surgical Suture (2014), 0 descendants of its own ## Recalls of this device - Dec 9, 2020 · Class II · Z-0949-2021: Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture - Aug 3, 2020 · Class II · Z-0010-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0011-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0012-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0013-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0015-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0016-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0018-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0019-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0020-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0025-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0041-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0045-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0014-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0017-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0021-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0022-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0024-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0032-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0034-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0036-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0038-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0043-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0044-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0047-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0026-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0027-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0028-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0029-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0030-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0031-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0035-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0037-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0039-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0040-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0023-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0033-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0042-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0046-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0048-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. - Aug 3, 2020 · Class II · Z-0049-2021: The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. ## Indications for use PGLA 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 and neurological tissues. PGLA suture is provided sterile as a single use device. Fast absorbing PGLA surgical suture is indicated for use in superficial soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. PGLA Quick suture is provided sterile as a single use device. Source page: https://510kreport.com/device/K120556 Methodology: https://510kreport.com/methodology