Cleared Traditional

K082089 - PRUMYX CREAM

K082089 · Prugen, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
173d
Days
-
Risk

K082089 is an FDA 510(k) clearance for the PRUMYX CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Prugen, Inc. (Chicago, US). The FDA issued a Cleared decision on January 13, 2009 after a review of 173 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 - K082089

510(k) Number K082089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2008
Decision Date January 13, 2009
Days to Decision 173 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
58d slower than avg
Panel avg: 115d · This submission: 173d
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 706
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K082089 · PRUMYX CREAM
Download PDF FDA Summary Prugen, Inc.