# K926167: Polyviolene Suture-Revised Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Look, Inc.
- Decided: Dec 17, 1993 after 381 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
144 later devices descend from it; 1 cites it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- 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
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (2008), 48 descendants of its own

Source page: https://510kreport.com/device/K926167
Methodology: https://510kreport.com/methodology