Cleared Traditional

K150985 - Medihoney Wound Gel

K150985 · Derma Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
219d
Days
-
Risk

K150985 is an FDA 510(k) clearance for the Medihoney Wound Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences, Inc. (Toronto, Orntario, CA). The FDA issued a Cleared decision on November 19, 2015 after a review of 219 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 Derma Sciences, Inc. devices

FDA 510(k) Submission Details - K150985

510(k) Number K150985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2015
Decision Date November 19, 2015
Days to Decision 219 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 115d · This submission: 219d
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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