Cleared Traditional

K050032 - EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS

K050032 · Euromed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
495d
Days
-
Risk

K050032 is an FDA 510(k) clearance for the EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Euromed, Inc. (North Attleboro, US). The FDA issued a Cleared decision on May 17, 2006 after a review of 495 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K050032

510(k) Number K050032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2005
Decision Date May 17, 2006
Days to Decision 495 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
380d slower than avg
Panel avg: 115d · This submission: 495d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K050032 · EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
Download PDF FDA Summary Euromed, Inc.