Cleared Traditional

PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border (K192463) - FDA 510(k) Clearance

K192463 · Winner Medical Co., Ltd. · General & Plastic Surgery device
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May 2020
Decision
248d
Days
-
Risk

K192463 is an FDA 510(k) clearance for the PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB F.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 14, 2020 after a review of 248 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 K192463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2019
Decision Date May 14, 2020
Days to Decision 248 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 115d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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