Cleared Traditional

CLARUS SPINEPEN MODEL 2126 (K955598) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955598 · Clarus Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
60d
Days
Class 2
Risk

K955598 is an FDA 510(k) clearance for the CLARUS SPINEPEN MODEL 2126. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clarus Medical Systems, Inc. devices

Submission Details

510(k) Number K955598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1995
Decision Date February 06, 1996
Days to Decision 60 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GWG Endoscope, Neurological

All 46
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K955598.
NEUROLOGICAL ENDOSCOPE
K970162 · Richard Wolf Medical Instruments Corp. · Oct 1997
AESCULAP ANGLED NEUROENDOSCOPES
K964281 · Aesculap, Inc. · Apr 1997
AESCULAP VENTRICULOSCOPE SYSTEM
K954394 · Aesculap, Inc. · Mar 1996
NONPOWERED NEUROSURGICAL INSTRUMENT
K953173 · United States Surgical, A Division of Tyco Healthc · Oct 1995
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
K945572 · Johnson & Johnson Professionals, Inc. · Feb 1995
AESCULAP NEUROENDOSCOPE
K941239 · Aesculap, Inc. · Jul 1994