Cleared Traditional

K092297 - ELETONE CREAM

K092297 · Ferndale Pharma Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
72d
Days
-
Risk

K092297 is an FDA 510(k) clearance for the ELETONE CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Ferndale Pharma Group, Inc. (Ferndale, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 72 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.

FDA 510(k) Submission Details - K092297

510(k) Number K092297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date October 09, 2009
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 665
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K092297.
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
K092826 · American Biotech Labs · Nov 2009
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
K083133 · Andover Healthcare, Inc. · Oct 2009
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
K091354 · Acrymed, Inc. · Oct 2009
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
K090254 · Convatec, A Division of E.R. Squibb & Sons, LLC · Sep 2009
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
K092232 · Puricore, Inc. · Aug 2009
TT-102
K081246 · Tissue Technologies Holdings, LLC · Aug 2009
K092297 · ELETONE CREAM
Download PDF FDA Summary Ferndale Pharma Group…