Cleared Traditional

K043296 - COLACTIVE AG COLLAGEN WITH SILVER ANTIM...

K043296 · Covalontechnologies, Inc. · General & Plastic Surgery device
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Jun 2005
Decision
189d
Days
-
Risk

K043296 is an FDA 510(k) clearance for the COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Covalontechnologies, Inc. (Largo, US). The FDA issued a Cleared decision on June 6, 2005 after a review of 189 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 Covalontechnologies, Inc. devices

FDA 510(k) Submission Details - K043296

510(k) Number K043296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2004
Decision Date June 06, 2005
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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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