Cleared Special

K990860 - VIEWPOINT MICROSCOPE OPTION

K990860 is an FDA 510(k) clearance for VIEWPOINT MICROSCOPE OPTION, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 14-day FDA review.

K990860 · Philips Medical Systems (Cleveland), Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
14d
Days
Class 2
Risk

K990860 is an FDA 510(k) clearance for the VIEWPOINT MICROSCOPE OPTION. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on March 30, 1999 after a review of 14 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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K990860

510(k) Number K990860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1999
Decision Date March 30, 1999
Days to Decision 14 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
134d faster than avg
Panel avg: 148d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 341
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K990860.
VECTORVISION2
K983831 · Brainlab AG · May 1999
OPTICAL TRACKING SYSTEM (OTS)
K990632 · Radionics, Inc. · Apr 1999
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
K990214 · Surgical Navigation Technologies, Inc. · Apr 1999
VIEWPOINT PASSIVE TOOL OPTION
K990868 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
K990326 · Radionics Software Applications, Inc. · Mar 1999
TRAJECTORY GUIDE, MODEL # TGX-XXX
K983539 · Image-Guided Neurologics, Inc. · Feb 1999