Cleared Special

K100958 - MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES

K100958 is an FDA 510(k) clearance for MODIFICATION TO: MICROBLADE SHAVER AND ..., 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 107-day FDA review.

K100958 · Baxano, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
107d
Days
Class 2
Risk

K100958 is an FDA 510(k) clearance for the MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Baxano, Inc. (San Jose, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 107 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K100958

510(k) Number K100958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2010
Decision Date July 23, 2010
Days to Decision 107 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
42d faster than avg
Panel avg: 149d · This submission: 107d
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 K100958.
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