Cleared Traditional

K960394 - SURESKIN STANDARD

K960394 · Euromed A/S · General & Plastic Surgery device
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Mar 1996
Decision
32d
Days
-
Risk

K960394 is an FDA 510(k) clearance for the SURESKIN STANDARD. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Euromed A/S (North Attleboro, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 32 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 - K960394

510(k) Number K960394 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 29, 1996
Decision Date March 01, 1996
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K960394.
BIO-DRESSING, STERILE ISLAND DRESSING
K961098 · K. W. Griffen Co. · May 1996
DERMASEAL
K960847 · Bellingham Medical, Inc. · Apr 1996
SURESKIN BORDER
K960393 · Euromed A/S · Mar 1996
SURESKIN THIN
K960404 · Euromed A/S · Mar 1996
DUKAL TRANSPARENT WOUND DRESSING
K955476 · Dukal Corp. · Jan 1996
SPYROCOLLOID WOUND DRESSING
K955383 · Polymedica Industries, Inc. · Dec 1995