Cleared Traditional

K991256 - VIEWPOINT ENT/ORTHOPEDIC OPTION

K991256 is the FDA 510(k) clearance for VIEWPOINT ENT/ORTHOPEDIC OPTION by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K991256 · Philips Medical Systems (Cleveland), Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
178d
Days
Class 2
Risk

K991256 is an FDA 510(k) clearance for the VIEWPOINT ENT/ORTHOPEDIC 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 October 8, 1999 after a review of 178 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 (Cleveland), Inc. devices

Submission Details

510(k) Number K991256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date October 08, 1999
Days to Decision 178 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
30d slower than avg
Panel avg: 148d · This submission: 178d
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 K991256.
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc. · Feb 2000
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K993239 · Stryker Corp. · Jan 2000
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K991706 · Stryker Corp. · Dec 1999
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
K992882 · Elekta Instrument AB · Sep 1999
@ TARGET
K983410 · Brainlab AG · Sep 1999
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
K992721 · Radionics, Inc. · Sep 1999