Cleared Traditional

K082296 - COPA AMD

K082296 · Covidien Lp, Formerly Registered AS Tyco Healthcar · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
198d
Days
-
Risk

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.

View all Covidien Lp, Formerly Registered AS Tyco Healthcar devices

FDA 510(k) Submission Details - K082296

510(k) Number K082296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2008
Decision Date February 26, 2009
Days to Decision 198 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
83d slower than avg
Panel avg: 115d · This submission: 198d
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 609
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