# K984374: Surgisorb

- Pathway: 510(k) (Traditional)
- Applicant: Samyang Corp.
- Decided: Jun 4, 1999 after 179 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
No predicates in its family tree.
14 later devices descend from it; 7 cite it directly.
0 of 15 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) Dexon® II polyglycolic acid, synthetic absorbable surgical sutures with polycaprolate coating system: named in the summary without a submission number

## Most influential descendants
- K031443: Lsi Solutions Suture Quick Load Products (2003), 7 descendants of its own
- K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme (2010), 5 descendants of its own
- K160529: Pledgeted COR-SUTURE QUICK LOAD (2016), 1 descendant of its own
- K141206: Edwards Lifesciences Thruport Knotting System (2015), 1 descendant of its own
- K222783: MD Mattress Suture Placement Device (2024), 0 descendants of its own

## Indications for use
GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL TISSUE.

Source page: https://510kreport.com/device/K984374
Methodology: https://510kreport.com/methodology