Cleared Traditional

MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY (K072956) - FDA 510(k) Clearance

K072956 · Derma Sciences, Inc. · General & Plastic Surgery device
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Nov 2007
Decision
19d
Days
-
Risk

K072956 is an FDA 510(k) clearance for the MEDIHONEY PRIMARY DRESSINGS 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 November 7, 2007 after a review of 19 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Derma Sciences, Inc. devices

Submission Details

510(k) Number K072956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2007
Decision Date November 07, 2007
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 189
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K072956.
PRONTOSAN WOUND IRRIGATION SOLUTION
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