Cleared Traditional

K020318 - SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES

K020318 · Scivolutions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
369d
Days
-
Risk

K020318 is an FDA 510(k) clearance for the SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Scivolutions, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on February 3, 2003 after a review of 369 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Scivolutions, Inc. devices

FDA 510(k) Submission Details - K020318

510(k) Number K020318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2002
Decision Date February 03, 2003
Days to Decision 369 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
254d slower than avg
Panel avg: 115d · This submission: 369d
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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