# K915835: Coated Vicryl* II

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Mar 23, 1992 after 90 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
162 later devices descend from it; 2 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014183: Afb (Absorbable Foam Buttress) (2002), 145 descendants of its own
- K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 143 descendants of its own
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 102 descendants of its own
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2004), 77 descendants of its own
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration (2004), 69 descendants of its own

Source page: https://510kreport.com/device/K915835
Methodology: https://510kreport.com/methodology