# K232204: ReyaGel (RG03 - MTP gel 3mL)

- Pathway: 510(k) (Traditional)
- Applicant: Fettech
- Decided: Apr 19, 2024 after 269 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: 8 generations back to K921895 (1992). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172593: XCelliStem Wound Powder, Stemsys (2018) Summary page 4.

## Indications for use
ReyaGel is intended for the management of wounds that include: * Partial and full thickness wounds * Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers * Second degree burns * Surgical wounds - donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence * Trauma wounds - abrasions, lacerations, and skin tears * Tunneled/undermined wounds * Draining wounds

Source page: https://510kreport.com/device/K232204
Methodology: https://510kreport.com/methodology