# K232758: Comatryx OTC

- Pathway: 510(k) (Traditional)
- Applicant: Strukmyer Medical, LLC
- Decided: Dec 1, 2023 after 84 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 3 generations back to K913023 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213092: Cellusheet, Cellufil, Human Biosciences, Inc. (2021) Summary page 4.

## Indications for use
The device is intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns

Source page: https://510kreport.com/device/K232758
Methodology: https://510kreport.com/methodology