Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) (K221754)
Description
Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) by Winner Medical Co., Ltd., an FDA 510(k) cleared unknown device.
Regulatory Information
FDA Database
View on FDA DatabasePredicate lineage for K221754
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) (K221754) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, S... | Winner Medical Co., Ltd. | 2020 |
| K180570 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressi... | Argentum Medical, LLC | 2019 |
Trace the full predicate network for K221754
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.