Cleared Special

K080494 - BAXANO ULTRA LOW PROFILE RONGEUR (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080494 · Baxano, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
11d
Days
Class 2
Risk

K080494 is an FDA 510(k) clearance for the BAXANO ULTRA LOW PROFILE RONGEUR. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Baxano, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on March 4, 2008 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxano, Inc. devices

Submission Details

510(k) Number K080494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2008
Decision Date March 04, 2008
Days to Decision 11 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 148d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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 Neurology devices follow this clearance model.

Regulatory Peers - HAE Rongeur, Manual

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