Cleared Traditional

K112094 - BRAIN BIOPSY NEEDLE

K112094 is an FDA 510(k) clearance for BRAIN BIOPSY NEEDLE, manufactured by Ad-Tech Medical Instrument Corp. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K112094 · Ad-Tech Medical Instrument Corp · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
277d
Days
Class 2
Risk

K112094 is an FDA 510(k) clearance for the BRAIN BIOPSY NEEDLE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Stoughton, US). The FDA issued a Cleared decision on April 24, 2012 after a review of 277 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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.

FDA 510(k) Submission Details - K112094

510(k) Number K112094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2011
Decision Date April 24, 2012
Days to Decision 277 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
128d slower than avg
Panel avg: 149d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 402
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K112094.
MICROTARGETING XL STAR DRIVE SYSTEM
K121950 · FHC, Inc. · Jul 2012
RENAISSANCE
K120812 · Mazor Robotics , Ltd. · Jul 2012
PRAEZIS PLUS
K110644 · Tatramed Spol. S.R.O. · May 2012
SURGICASE GUIDE
K111558 · Materialise NV · Mar 2012
GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
K112469 · Sonowand AS · Mar 2012
RENAISSANCE SYSTEM
K113228 · Mazor Robotics , Ltd. · Dec 2011