Cleared Traditional

K153565 - DONASORB SILVER WOUND DRESSING

K153565 · Virchow Biotech Pvt, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
283d
Days
-
Risk

K153565 is an FDA 510(k) clearance for the DONASORB SILVER WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Virchow Biotech Pvt, Ltd. (Portland, US). The FDA issued a Cleared decision on September 22, 2016 after a review of 283 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.

FDA 510(k) Submission Details - K153565

510(k) Number K153565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2015
Decision Date September 22, 2016
Days to Decision 283 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
168d slower than avg
Panel avg: 115d · This submission: 283d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K153565.
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