Cleared Traditional

K993568 - MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L

K993568 is an FDA 510(k) clearance for MACHIDA FLEXIBLE NEURO-ENDOSCOPE, manufactured by Machida Endoscope Co., Ltd.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K993568 · Machida Endoscope Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
144d
Days
Class 2
Risk

K993568 is an FDA 510(k) clearance for the MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Machida Endoscope Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on March 13, 2000 after a review of 144 days - within the typical 510(k) review window.

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 Machida Endoscope Co., Ltd. devices

FDA 510(k) Submission Details - K993568

510(k) Number K993568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1999
Decision Date March 13, 2000
Days to Decision 144 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
4d faster than avg
Panel avg: 148d · This submission: 144d
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 82
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K993568.
KSEA NEURO-FIBERSCOPE
K002788 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
NAVIGUS PEEL AWAY INTRODUCER
K002330 · Image-Guided Neurologics, Inc. · Oct 2000
KSEA BIPOLAR COAGULATING ELECTRODES
K001630 · Karl Storz Endoscopy · Jul 2000
DCI ENDOSCOPE
K993539 · KARL STORZ Endoscopy-America, Inc. · Dec 1999
MITAKA POINT SETTER
K991989 · Mitaka USA, Inc. · Aug 1999
KSEA NEURO-FIBERSCOPE
K991069 · KARL STORZ Endoscopy-America, Inc. · Jun 1999