Cleared Special

Ag Foam Dressing Non-Adhesive (OTC) (K221754) - FDA 510(k) Clearance

Also marketed or referenced as:
Ag Foam Dressing Adhesive (OTC) Silicone Ag Foam Dressing (OTC) Silicone Ag Foam Dressing with Border (OTC)
K221754 · Winner Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
215d
Days
-
Risk

K221754 is an FDA 510(k) clearance for the Ag Foam Dressing Non-Adhesive (OTC). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 17, 2023 after a review of 215 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Winner Medical Co., Ltd. devices

Submission Details

510(k) Number K221754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2022
Decision Date January 17, 2023
Days to Decision 215 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 115d · This submission: 215d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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