Cleared Traditional

K991256 - VIEWPOINT ENT/ORTHOPEDIC OPTION

K991256 is an FDA 510(k) clearance for VIEWPOINT ENT/ORTHOPEDIC OPTION, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K991256

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.

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 K991256.
3D1 MICROPOSITIONING HEADSTAGE
K993501 · Scientific Tools, Inc. · Nov 1999
AXON MP-1 MICROPOSITIONER
K990683 · Axon Instruments, Inc. · Nov 1999
THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
K992843 · Ohio Medical Instrument Co., Inc. · Nov 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