Cleared Traditional

K103054 - PERIOPATCH

K103054 · Izun Pharmaceuticals Corporation · General & Plastic Surgery device
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Feb 2011
Decision
115d
Days
-
Risk

K103054 is an FDA 510(k) clearance for the PERIOPATCH. Classified as Oral Wound Dressing (product code OLR).

Submitted by Izun Pharmaceuticals Corporation (New York, US). The FDA issued a Cleared decision on February 7, 2011 after a review of 115 days - within the typical 510(k) review window.

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 - K103054

510(k) Number K103054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2010
Decision Date February 07, 2011
Days to Decision 115 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

OLR Device Classification - Class 0,

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 42
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K103054 · PERIOPATCH
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