# K172338: Catasyn Advanced Technology Wound Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Synedgen, Inc.
- Decided: Feb 21, 2018 after 203 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973725 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973725: Bionect Clear Hydrogel, Fidia Pharmaceutical Corp. (1998) Summary page 4.
- K984264: Modification of Bionect Clear Hydrogel, Fidia Pharmaceutical Corp. (1999) Summary page 4.

## Indications for use
Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin. Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites) and superficial and partial thickness (second degree) burns.

Source page: https://510kreport.com/device/K172338
Methodology: https://510kreport.com/methodology