Cleared Traditional

K082910 - CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES

K082910 · Aso, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
260d
Days
-
Risk

K082910 is an FDA 510(k) clearance for the CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Aso, LLC (Appollo Beach, US). The FDA issued a Cleared decision on June 17, 2009 after a review of 260 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 - K082910

510(k) Number K082910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date June 17, 2009
Days to Decision 260 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
145d slower than avg
Panel avg: 115d · This submission: 260d
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 668
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K082910.
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K082910 · CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES
Download PDF FDA Summary Aso, LLC