Cleared Traditional

Antibacterial Gel Wound Dressing (K231057) - FDA 510(k) Clearance

K231057 · Winner Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
232d
Days
-
Risk

K231057 is an FDA 510(k) clearance for the Antibacterial Gel Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 1, 2023 after a review of 232 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Winner Medical Co., Ltd. devices

Submission Details

510(k) Number K231057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2023
Decision Date December 01, 2023
Days to Decision 232 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 115d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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