Cleared Traditional

K032983 - SENSITIVE SKIN ANTIBACTERIAL BANDAGES

K032983 · Scivolution, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
251d
Days
-
Risk

K032983 is an FDA 510(k) clearance for the SENSITIVE SKIN ANTIBACTERIAL BANDAGES. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Scivolution, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on June 1, 2004 after a review of 251 days - an extended review 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: 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 Scivolution, Inc. devices

FDA 510(k) Submission Details - K032983

510(k) Number K032983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date June 01, 2004
Days to Decision 251 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 115d · This submission: 251d
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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