Cleared Traditional

MSS-28CS-301/701 NEEDLESCOPE (K013759) - FDA 510(k) Clearance

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

K013759 · Olympus Optical Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
280d
Days
Class 2
Risk

K013759 is an FDA 510(k) clearance for the MSS-28CS-301/701 NEEDLESCOPE. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Olympus Optical Co., Ltd. (Melville, US). The FDA issued a Cleared decision on August 20, 2002 after a review of 280 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 Olympus Optical Co., Ltd. devices

Submission Details

510(k) Number K013759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date August 20, 2002
Days to Decision 280 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
132d slower than avg
Panel avg: 148d · This submission: 280d
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 40
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K013759.
KARL STORZ Flexible Video-Neuro-Endoscope System
K161112 · KARL STORZ Endoscopy-America, Inc. · Sep 2016
MINOP Disposable Introducer 26F
K142315 · Aesculap, Inc. · Nov 2014
KSEA CLEARVISION II, MODEL 40334120
K072410 · KARL STORZ Endoscopy-America, Inc. · May 2008
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050 · KARL STORZ Endoscopy-America, Inc. · Jun 2002
PAEDISCOPE, MODEL # P010A AND PF011A
K014149 · Aesculap, Inc. · Mar 2002
KSEA MINIATURE NEUROENDOSCOPE
K002704 · KARL STORZ Endoscopy-America, Inc. · Nov 2000