# K954808: Ussc Polyproplene Suture

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Feb 27, 1996 after 131 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
77 later devices descend from it; 2 cite it directly.
0 of 78 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
- K050947: Modification to: Modified Uss Polypropylene Suture (2005), 76 descendants of its own
- K063778: Force Fiber Polyethylene Nonabsorbable Suture (2007), 69 descendants of its own
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures (2009), 29 descendants of its own
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture (2007), 23 descendants of its own
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need (2010), 15 descendants of its own

## Recalls of this device
- Dec 2, 2022 · Class II · Z-1179-2023: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Source page: https://510kreport.com/device/K954808
Methodology: https://510kreport.com/methodology