Cleared Traditional

K954394 - AESCULAP VENTRICULOSCOPE SYSTEM

K954394 is an FDA 510(k) clearance for AESCULAP VENTRICULOSCOPE SYSTEM, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K954394 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
171d
Days
Class 2
Risk

K954394 is an FDA 510(k) clearance for the AESCULAP VENTRICULOSCOPE SYSTEM. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 7, 1996 after a review of 171 days - an extended review 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: 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K954394

510(k) Number K954394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date March 07, 1996
Days to Decision 171 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
23d slower than avg
Panel avg: 148d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWG Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K954394.
1.2MM REUSABLE NEUROVIEW ENDOSCOPE
K961173 · Neuro Navigational Corp. · Jun 1996
ASPIRATION/IRRIGATION CATHETER
K961300 · Neuro Navigational Corp. · Jun 1996
DISPOSABLE NEUROVIEW INTRODUCER SHEATH
K960792 · Neuro Navigational Corp. · Apr 1996
DISPOSABLE NEUROVIEW OPERATING SHEATH
K954938 · Neuro Navigational Corp. · Mar 1996
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
K955351 · Neuro Navigational Corp. · Feb 1996
CLARUS SPINEPEN MODEL 2126
K955598 · Clarus Medical Systems, Inc. · Feb 1996