Cleared Traditional

K981480 - PHILIPS EASYGUIDE

K981480 is the FDA 510(k) clearance for PHILIPS EASYGUIDE by Philips Medical Systems, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K981480 · Philips Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
279d
Days
Class 2
Risk

K981480 is an FDA 510(k) clearance for the PHILIPS EASYGUIDE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on January 28, 1999 after a review of 279 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.

View all Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K981480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1998
Decision Date January 28, 1999
Days to Decision 279 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
131d slower than avg
Panel avg: 148d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K981480.
OPTICAL TRACKING SYSTEM (OTS)
K990632 · Radionics, Inc. · Apr 1999
VIEWPOINT MICROSCOPE OPTION
K990860 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
VIEWPOINT PASSIVE TOOL OPTION
K990868 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
K984245 · Radionics, Inc. · Dec 1998
OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
K983669 · Radionics, Inc. · Nov 1998
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
K983603 · Radionics, Inc. · Nov 1998