Cleared Special

K982364 - WIRELESS STANDARD PROBE

K982364 is the FDA 510(k) clearance for WIRELESS STANDARD PROBE by Radionics, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 30-day FDA review.

K982364 · Radionics, Inc. · Neurology device

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Aug 1998

Decision

30d

Days

Class 2

Risk

K982364 is an FDA 510(k) clearance for the WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on August 5, 1998 after a review of 30 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Radionics, Inc. devices

Submission Details

510(k) Number	K982364 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 06, 1998
Decision Date	August 05, 1998
Days to Decision	30 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

118d faster than avg

Panel avg: 148d · This submission: 30d

Pathway characteristics

Modification to existing cleared device.

Device Classification

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 225

Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K982364.

REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME

K983603 · Radionics, Inc. · Nov 1998

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PHILIPS EASYGUIDE

K980820 · Philips Medical Systems, Inc. · Oct 1998

UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I

K981213 · Radionics, Inc. · Jul 1998

ATLASPLAN

K980584 · Radionics, Inc. · May 1998

LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND

K973684 · Elekta Instrument AB · Mar 1998

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K982364

Radionics, Inc.

Burlington, MA · US

LISA MISTERKA BENATI

Regulatory profile

56 submissions 56 cleared

100% clearance rate · Active in Neurology

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