Cleared Special

K080494 - BAXANO ULTRA LOW PROFILE RONGEUR

K080494 is an FDA 510(k) clearance for BAXANO ULTRA LOW PROFILE RONGEUR, manufactured by Baxano, Inc.. The device is a Class 2 Neurology device with product code HAE cleared through the Special 510(k) pathway after a 11-day FDA review.

K080494 · Baxano, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K080494

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 149d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

HAE Device Classification - Class 2, Special Controls

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

All 31
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K080494.
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
K100958 · Baxano, Inc. · Jul 2010
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K092227 · Integra Lifesciences Corp. · Feb 2010
INSTRUMED RONGEUR
K081651 · Instrumed International, Inc. · Aug 2008
MICROBLADE SHAVER AND ACCESSORIES
K063231 · Baxano, Inc. · Apr 2007
ULTRA LOW PROFILE RONGEUR
K062711 · Baxano, Inc. · Mar 2007
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
K023868 · Dannoritzer Medical Instruments · Feb 2003