# K233111: ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC

- Pathway: 510(k) (Traditional)
- Applicant: Foshan United Medical Technologies, Ltd.
- Decided: May 24, 2024 after 240 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172570: ALGS6 Ag Alginate Wound Dressing, Foshan United Medical Technologies, Ltd. (2018) Summary page 5.

## Indications for use
Under the supervision of a healthcare professional, ALGS2 Ag Alginate Wound Dressing may be used for the management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, partial thickness burns. For Over-the-Counter use (Pad Configurations), ALGS2 Ag Alginate Wound Dressing may be used for: * Minor Abrasions * Minor Lacerations * Minor cuts * Minor scalds and burns

Source page: https://510kreport.com/device/K233111
Methodology: https://510kreport.com/methodology