Cleared Special

K142315 - MINOP Disposable Introducer 26F

K142315 is an FDA 510(k) clearance for MINOP Disposable Introducer 26F, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code GWG cleared through the Special 510(k) pathway after a 87-day FDA review.

K142315 · Aesculap, Inc. · Neurology device
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Nov 2014
Decision
87d
Days
Class 2
Risk

K142315 is an FDA 510(k) clearance for the MINOP Disposable Introducer 26F. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 14, 2014 after a review of 87 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142315

510(k) Number K142315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2014
Decision Date November 14, 2014
Days to Decision 87 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 149d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Medcomp (Medical Components, Inc.)
CORINA DUFFY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWG Endoscope, Neurological

All 92
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K142315.
TIPCAM 1S 3D System
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Apollo System
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APOLLO SYSTEM
K132931 · Penumbra, Inc. · Jan 2014
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K131434 · Visionsense, Ltd. · Jul 2013
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
K081102 · Visionsense, Ltd. · May 2008
K142315 · MINOP Disposable Introducer 26F
Download PDF Aesculap, Inc.