# K162017: Ross Ru Wound Dressing Gel

- Pathway: 510(k) (Traditional)
- Applicant: Biotd S.A.
- Decided: Apr 20, 2017 after 273 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: 6 generations back to K914579 (1992). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092826: Asap Antimicrobial Silver Wound Dressing Gel, American Biotech Labs (2009) Summary page 4.

## Indications for use
Ross Ru Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.

Source page: https://510kreport.com/device/K162017
Methodology: https://510kreport.com/methodology