Cleared Traditional

K032983 - SENSITIVE SKIN ANTIBACTERIAL BANDAGES

K032983 · Scivolution, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
PCCP Authorized No
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

All 700
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K032983.
ANTIMICROBIAL ALGINATE DRESSING
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SUILE OINTMENT WOUND DRESSING
K041013 · Hedonist Biochemical Technologies Co., Ltd. · Jul 2004
BIODERM SCIENCES WOUND DRESSING
K040683 · Bioderm Sciences, Inc. · Jun 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869 · Coloplast Corp. · May 2004
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
K033453 · Tyco Healthcare · Apr 2004
CURAD SILVER ACTIVE GEL BANDAGE
K032462 · Beiersdorf AG · Feb 2004
K032983 · SENSITIVE SKIN ANTIBACTERIAL BANDAGES
Download PDF FDA Summary Scivolution, Inc.