# K221720: Extra Silver Gelling Fiber Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: Dec 21, 2022 after 191 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: 5 generations back to K914604 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210466: Silver Gelling Fiber Dressing, Winner Medical Co., Ltd. (2022) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional. Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: • Partial thickness (second degree) burns; • Pressure ulcers (partial and full thickness); • Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); • Diabetic foot ulcers; • Surgical wounds that heal by primary intent such as dermatological and surgical incisions; • Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites; • Traumatic wounds Extra Silver Gelling Fiber Dressing may be used for the management of: • Minor Abrasions • Minor Lacerations • Minor cuts • Minor scalds and burns

Source page: https://510kreport.com/device/K221720
Methodology: https://510kreport.com/methodology