Cleared Traditional

K972336 - DERMAMEND HYDROGEL GAUZE DRESSING

K972336 is an FDA 510(k) clearance for DERMAMEND HYDROGEL GAUZE DRESSING, manufactured by Dermarx Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K972336 · Dermarx Corp. · General & Plastic Surgery device
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Jul 1997
Decision
36d
Days
Class 1
Risk

K972336 is an FDA 510(k) clearance for the DERMAMEND HYDROGEL GAUZE DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Dermarx Corp. (Denver, US). The FDA issued a Cleared decision on July 29, 1997 after a review of 36 days - a notably fast clearance 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: 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 Dermarx Corp. devices

FDA 510(k) Submission Details - K972336

510(k) Number K972336 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1997
Decision Date July 29, 1997
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
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 107
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K972336.
OPPURTUNITY TRACHEOSTOMY CARE KIT
K971091 · Opportunity, Inc. · Sep 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997
DERMAGRAN WOUND MANAGEMENT SYSTEM
K970660 · Derma Sciences, Inc. · Aug 1997
EPITECH ISLAND DRESSINGS
K971337 · Rynel, Ltd. Inc. · Jul 1997
DERMAMEND FOAM ISLAND DRESSING
K970600 · Dermarx Corp. · May 1997
ALLCLENZ WOUND CLEANSER
K965120 · Dpt Laboratories, Ltd. · Mar 1997