# K213473: Antimicrobial Gelling Fiber Dressing with PHMB

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions, Ltd.
- Decided: Oct 26, 2023 after 728 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 K914604 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181197: PHMB Foam Wound Dressing, Advanced Medical Solutions, Ltd. (2018) Summary page 4.
- K173675: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber, Convatec Limited (2018) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional, the Antimicrobial Gelling Fiber Dressing with PHMB is indicated for the management of: • Post-surgical incisions • Pressure ulcers • Diabetic ulcers • Venous stasis ulcers • Donor sites • Abrasions • Lacerations • Superficial and Partial thickness burns • Dermatologic disorders • Other wounds inflicted by trauma The Antimicrobial Gelling Fiber Dressing with PHMB may be used for the management of: • Minor abrasions • Minor lacerations • Minor cuts • Minor scalds and bums

Source page: https://510kreport.com/device/K213473
Methodology: https://510kreport.com/methodology