Cleared Traditional

K092348 - POLY FIT HIGH HYDRATING ANTIMICROBIAL D...

K092348 · Polyremedy, Inc. · General & Plastic Surgery device
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Apr 2010
Decision
247d
Days
-
Risk

K092348 is an FDA 510(k) clearance for the POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Polyremedy, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on April 8, 2010 after a review of 247 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 Polyremedy, Inc. devices

FDA 510(k) Submission Details - K092348

510(k) Number K092348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date April 08, 2010
Days to Decision 247 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 115d · This submission: 247d
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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