Cleared Traditional

K132436 - VARIOGUIDE DRILL KIT

K132436 is an FDA 510(k) clearance for VARIOGUIDE DRILL KIT, manufactured by Mri Interventions, Inc.. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K132436 · Mri Interventions, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
227d
Days
Class 2
Risk

K132436 is an FDA 510(k) clearance for the VARIOGUIDE DRILL KIT. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on March 20, 2014 after a review of 227 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mri Interventions, Inc. devices

FDA 510(k) Submission Details - K132436

510(k) Number K132436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2013
Decision Date March 20, 2014
Days to Decision 227 days
Submission Type Traditional
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
79d slower than avg
Panel avg: 148d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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.

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