# K160872: PolyPlex Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Global Health Solutions, LLC
- Decided: Nov 23, 2016 after 238 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: 1 generation back to K041013 (2004). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082296: Copa Amd, Covidien Lp, Formerly Registered AS Tyco Healthcar (2009) Summary page 4.
- K041013: Suile Ointment Wound Dressing, Hedonist Biochemical Technologies Co., Ltd. (2004) Summary page 4.

## Cited in the summary but kept off the family tree
- K010882: Blue Sky Bio Dental Implant System, Blue Sky Bio (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K181315: Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing (2019), 1 descendant of its own
- K221755: Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (2023), 0 descendants of its own
- K183681: Protego Antimicrobial Wound Dressing (2019), 0 descendants of its own
- K171191: Hexagen Derm (2017), 0 descendants of its own

## Indications for use
Under the management of a healthcare professional, PolyPlex 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. It can be used during wound dressing changes to soften encrusted wound dressings.

Source page: https://510kreport.com/device/K160872
Methodology: https://510kreport.com/methodology