Cleared Traditional

K971337 - EPITECH ISLAND DRESSINGS

K971337 is an FDA 510(k) clearance for EPITECH ISLAND DRESSINGS, manufactured by Rynel, Ltd. Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K971337 · Rynel, Ltd. Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
90d
Days
Class 1
Risk

K971337 is an FDA 510(k) clearance for the EPITECH ISLAND DRESSINGS. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Rynel, Ltd. Inc. (Boothbay, US). The FDA issued a Cleared decision on July 9, 1997 after a review of 90 days - within the typical 510(k) review window.

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.

View all Rynel, Ltd. Inc. devices

FDA 510(k) Submission Details - K971337

510(k) Number K971337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date July 09, 1997
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K971337.
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
DERMAMEND HYDROGEL GAUZE DRESSING
K972336 · Dermarx Corp. · Jul 1997
DERMAMEND FOAM ISLAND DRESSING
K970600 · Dermarx Corp. · May 1997
ALLCLENZ WOUND CLEANSER
K965120 · Dpt Laboratories, Ltd. · Mar 1997
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
K964231 · North American Sterilization & Packaging Co. · Mar 1997