Cleared Traditional

K093156 - PRUCLAIR NONSTEROIDAL CREAM

K093156 · Prugen IP Holdings, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
261d
Days
-
Risk

K093156 is an FDA 510(k) clearance for the PRUCLAIR NONSTEROIDAL CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Prugen IP Holdings, Inc. (Scottsdale, US). The FDA issued a Cleared decision on June 24, 2010 after a review of 261 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 - K093156

510(k) Number K093156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2009
Decision Date June 24, 2010
Days to Decision 261 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
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K093156 · PRUCLAIR NONSTEROIDAL CREAM
Download PDF FDA Summary Prugen IP Holdings, I…