Cleared Traditional

ALLWOUND (K053476) - FDA 510(k) Clearance

K053476 · At Squared, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
194d
Days
-
Risk

K053476 is an FDA 510(k) clearance for the ALLWOUND. Classified as Wound Dressings Containing Topical Analgesics (product code SEJ).

Submitted by At Squared, LLC (Washington, US). The FDA issued a Cleared decision on June 26, 2006 after a review of 194 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.

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Submission Details

510(k) Number K053476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2005
Decision Date June 26, 2006
Days to Decision 194 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
79d slower than avg
Panel avg: 115d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEJ Wound Dressings Containing Topical Analgesics
Device Class -
Definition A Solid Wound Dressing Containing Topical Analgesics Is Used To Cover And Protect A Wound, To Absorb Exudate, To Maintain Appropriate Moisture Balance Within The Wound, And To Reduce Pain. A Wound Dressing Formulated As A Gel, Cream Or Ointment Containing Topical Analgesics Is Used To Maintain Appropriate Moisture Balance Within The Wound And To Reduce Pain.