Cleared Special

K113533 - NEURO CHECK DEVICE WITH IO-FLEX WIRE

K113533 is an FDA 510(k) clearance for NEURO CHECK DEVICE WITH IO-FLEX WIRE, 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 133-day FDA review.

K113533 · Baxano, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
133d
Days
Class 2
Risk

K113533 is an FDA 510(k) clearance for the NEURO CHECK DEVICE WITH IO-FLEX WIRE. 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 April 11, 2012 after a review of 133 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 - K113533

510(k) Number K113533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date April 11, 2012
Days to Decision 133 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
16d faster than avg
Panel avg: 149d · This submission: 133d
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 K113533.
OSTEOMED NEURO RONGEUR
K131851 · Osteomed · Dec 2013
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
K130541 · Symmetry Surgical · Aug 2013
IO-TOME DEVICE
K113073 · Baxano, Inc. · Jul 2012
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