# K172747: Hyaluronic Acid Topical Wound Cream

- Pathway: 510(k) (Traditional)
- Applicant: Virchow Biotech Pvt, Ltd.
- Decided: Apr 27, 2018 after 227 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 K830708 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963004: Bionect Cream, Fidia Pharmaceutical Corp. (1997) Summary page 5.

## Indications for use
Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), first and second degree burns. Hyaluronic Acid Topical Wound Cream 0.2%w/w is indicated for dressing and management of minor burns, minor superficial cuts, minor lacerations, and minor abrasions; and minor irritation of the skin.

Source page: https://510kreport.com/device/K172747
Methodology: https://510kreport.com/methodology