# K963253: Synthetic Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Oct 8, 1996 after 50 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) USSC POLYSORB suture: named in the summary without a submission number

## Most influential descendants
- K970863: Modified Ussc* Polysorb Suture (1997), 8 descendants of its own
- K981935: Polysorb Suture (1998), 7 descendants of its own
- 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

## Recalls of this device
- May 3, 2017 · Class II · Z-2541-2017: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

## Indications for use
USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and/ or ligation and ophthalmic surgery but not use in cardiovascular or neural tissue.

Source page: https://510kreport.com/device/K963253
Methodology: https://510kreport.com/methodology