Cleared Traditional

K963039 - SURESKIN STANDARD, BORDER, AND THIN

K963039 · Euromed A/S · General & Plastic Surgery device
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Sep 1996
Decision
49d
Days
-
Risk

K963039 is an FDA 510(k) clearance for the SURESKIN STANDARD, BORDER, AND THIN. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Euromed A/S (North Attleboro, US). The FDA issued a Cleared decision on September 23, 1996 after a review of 49 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.

View all Euromed A/S devices

FDA 510(k) Submission Details - K963039

510(k) Number K963039 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 05, 1996
Decision Date September 23, 1996
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 457
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K963039.
ARGLAES FILM DRESSING
K970566 · Maersk Medical, Ltd. · Jul 1997
HYDROCOLLOID WOUND DRESSINGS
K971126 · Innovative Technologies , Ltd. · Jun 1997
MITRAFLEX PIGMENTED WOUND DRESSING
K964701 · Polymedica Industries, Inc. · Feb 1997
SIGNALDRESS
K962590 · Convatec, A Division of E.R. Squibb & Sons · Sep 1996
TECNOL SALINE WET DRESSING
K954243 · Tecnol Medical Products, Inc. · Nov 1995
DERMAGRAN HYDROPHILIC OINTMENT
K954739 · Derma Sciences, Inc. · Nov 1995