Cleared Traditional

K964281 - AESCULAP ANGLED NEUROENDOSCOPES

K964281 is the FDA 510(k) clearance for AESCULAP ANGLED NEUROENDOSCOPES by Aesculap, Inc.. It is a Class 2 Neurology device (product code GWG) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K964281 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
175d
Days
Class 2
Risk

K964281 is an FDA 510(k) clearance for the AESCULAP ANGLED NEUROENDOSCOPES. 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 April 21, 1997 after a review of 175 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

Submission Details

510(k) Number K964281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date April 21, 1997
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
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 53
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K964281.
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
K982837 · Karl Storz Endoscopy · Nov 1998
INCL II ENDOSCOPE
K963642 · Sofamor Danek USA,Inc. · Mar 1998
NEUROLOGICAL ENDOSCOPE
K970162 · Richard Wolf Medical Instruments Corp. · Oct 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