# K063536: Polysorb* Synthetic Absorbable Suture with Modified Packaging

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare Group
- Decided: Jan 29, 2007 after 68 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
Longest line of descent: 3 generations back to K961997 (1996). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981935: Polysorb Suture, United States Surgical, A Division of Tyco Healthc (1998) Summary page 1.

## Most influential descendants
- K073614: WG-Surgical Sutures with Needle (2008), 2 descendants of its own
- K200392: Rexsin (2020), 0 descendants of its own
- K173779: Rexmono, Pdrex (2018), 0 descendants of its own

## Indications for use
Polysorb* Synthetic Absorbable Suture with Modified Packaging is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Source page: https://510kreport.com/device/K063536
Methodology: https://510kreport.com/methodology