COPA AMD (K082296) - FDA 510(k) Clearance

K082296 is an FDA 510(k) clearance for the COPA AMD. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Covidien Lp, Formerly Registered AS Tyco Healthcar (Mansfield, US). The FDA issued a Cleared decision on February 26, 2009 after a review of 198 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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