Cleared Traditional

K101793 - MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY

K101793 · Derma Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
239d
Days
-
Risk

K101793 is an FDA 510(k) clearance for the MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences, Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 22, 2011 after a review of 239 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 - K101793

510(k) Number K101793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2010
Decision Date February 22, 2011
Days to Decision 239 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
124d slower than avg
Panel avg: 115d · This submission: 239d
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 648
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K100591 · Abigo Medical AB · Jan 2011
K101793 · MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
Download PDF FDA Summary Derma Sciences, Inc.