# K222025: G4Derm / G4Derm Plus Synthetic Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Gel4med, Inc.
- Decided: Oct 11, 2023 after 457 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: 2 generations back to K894541 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991202: Modification to Woun'dres, Coloplast Corp. (1999) Summary page 7.

## Indications for use
OTC: May be used for superficial wounds and abrasions and minor burns. Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing.

Source page: https://510kreport.com/device/K222025
Methodology: https://510kreport.com/methodology