Cleared Traditional

ANOVA CONTAINMENT DEVICE (K063461) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063461 · Anova Corporation · General & Plastic Surgery device
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Aug 2009
Decision
1002d
Days
Class 2
Risk

K063461 is an FDA 510(k) clearance for the ANOVA CONTAINMENT DEVICE. Classified as Mesh, Surgical, Metal (product code EZX), Class II - Special Controls.

Submitted by Anova Corporation (Washington, US). The FDA issued a Cleared decision on August 13, 2009 after a review of 1002 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Anova Corporation devices

Submission Details

510(k) Number K063461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2006
Decision Date August 13, 2009
Days to Decision 1002 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
887d slower than avg
Panel avg: 115d · This submission: 1002d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZX Mesh, Surgical, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.