Cleared Traditional

K924348 - AD-TECH'S BRAIN BIOPSY NEEDLE FOR STERE...

K924348 is an FDA 510(k) clearance for AD-TECH'S BRAIN BIOPSY NEEDLE FOR STERE..., 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 88-day FDA review.

K924348 · Ad-Tech Medical Instrument Corp · Neurology device
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Nov 1992
Decision
88d
Days
Class 2
Risk

K924348 is an FDA 510(k) clearance for the AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ad-Tech Medical Instrument Corp devices

FDA 510(k) Submission Details - K924348

510(k) Number K924348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date November 23, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
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 269
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K924348.
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