Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (K221755)
Description
Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing by Winner Medical Co., Ltd., an FDA 510(k) cleared unknown device.
Regulatory Information
FDA Database
View on FDA DatabasePredicate lineage for K221755
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. Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (K221755) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sp... | Winner Medical Co., Ltd. | 2019 |
| K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC ... | Tyco Healthcare | 2007 |
Trace the full predicate network for K221755
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.