# K183681: Protego Antimicrobial Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Global Health Solutions (Dba Turn Therapeutics)
- Decided: Oct 11, 2019 after 287 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 K041013 (2004). 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)
- K160872: PolyPlex Wound Dressing, Global Health Solutions, LLC (2016) Summary page 4.

## Indications for use
Under the management of a healthcare professional, Protego Antimicrobial Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, post-surgical incisions, trauma wounds, and abrasions.

Source page: https://510kreport.com/device/K183681
Methodology: https://510kreport.com/methodology