Cleared Traditional

K970660 - DERMAGRAN WOUND MANAGEMENT SYSTEM

K970660 is an FDA 510(k) clearance for DERMAGRAN WOUND MANAGEMENT SYSTEM, manufactured by Derma Sciences, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K970660 · Derma Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
172d
Days
Class 1
Risk

K970660 is an FDA 510(k) clearance for the DERMAGRAN WOUND MANAGEMENT SYSTEM. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Derma Sciences, Inc. (Rockville, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 172 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 - K970660

510(k) Number K970660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1997
Decision Date August 12, 1997
Days to Decision 172 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
57d slower than avg
Panel avg: 115d · This submission: 172d
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 208
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K970660.
OPPORTUNITY DRESSING CHANGE TRAY
K971090 · Opportunity, Inc. · Sep 1997
OPPURTUNITY TRACHEOSTOMY CARE KIT
K971091 · Opportunity, Inc. · Sep 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997
DERMAMEND HYDROGEL GAUZE DRESSING
K972336 · Dermarx Corp. · Jul 1997
EPITECH ISLAND DRESSINGS
K971337 · Rynel, Ltd. Inc. · Jul 1997
DERMAMEND FOAM ISLAND DRESSING
K970600 · Dermarx Corp. · May 1997
K970660 · DERMAGRAN WOUND MANAGEMENT SYSTEM
Download PDF FDA Summary Derma Sciences, Inc.