Cleared Traditional

HYALURONIC ACID TOPICAL WOUND CREAM (K172747) - FDA 510(k) Clearance

K172747 · Virchow Biotech Pvt, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
227d
Days
-
Risk

K172747 is an FDA 510(k) clearance for the HYALURONIC ACID TOPICAL WOUND CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Virchow Biotech Pvt, Ltd. (Portland, US). The FDA issued a Cleared decision on April 27, 2018 after a review of 227 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 Virchow Biotech Pvt, Ltd. devices

Submission Details

510(k) Number K172747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2017
Decision Date April 27, 2018
Days to Decision 227 days
Submission Type Traditional
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
112d slower than avg
Panel avg: 115d · This submission: 227d
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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