# K981935: Polysorb Suture

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jun 25, 1998 after 23 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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: 2 generations back to K961997 (1996). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970863: Modified Ussc* Polysorb Suture, United States Surgical, A Division of Tyco Healthc (1997) Summary page 1.

## Most influential descendants
- K063536: Polysorb* Synthetic Absorbable Suture with Modified Packaging (2007), 3 descendants of its own
- K202950: StitchKit COMBO (2021), 2 descendants of its own
- K073614: WG-Surgical Sutures with Needle (2008), 2 descendants of its own
- K211792: StitchKit (2021), 1 descendant of its own
- K221527: StitchKit (2023), 0 descendants of its own

## Recalls of this device
- Jun 15, 2018 · Class II · Z-2601-2018: Potential proplylene glycol contamination

## Indications for use
Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Source page: https://510kreport.com/device/K981935
Methodology: https://510kreport.com/methodology