Cleared Traditional

K083087 - ECOCEL

K083087 is an FDA 510(k) clearance for ECOCEL, manufactured by Polichem S.A. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K083087 · Polichem S.A · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
295d
Days
Class 1
Risk

K083087 is an FDA 510(k) clearance for the ECOCEL. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Polichem S.A (Rockville, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 295 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. 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 - K083087

510(k) Number K083087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2008
Decision Date August 07, 2009
Days to Decision 295 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
180d slower than avg
Panel avg: 115d · This submission: 295d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 186
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K083087.
MARATHON NO STING LIQUID SKIN PROTECTANT
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LIQUID BANDAGE
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SKIN BARRIER FILM
K092712 · Lodestar Products, Inc. · Feb 2010
CHESSON LABS LIQUID BANDAGE
K083913 · Chesson Laboratory Associates, Inc. · Jul 2009
GLUSEAL 90, MODEL GLU9010
K083752 · Glustitch, Inc. · Feb 2009
MRDH BANDAGE
K082703 · Marine Polymer Technologies, Inc. · Oct 2008