Cleared Traditional

K161112 - KARL STORZ Flexible Video-Neuro-Endosco...

K161112 is the FDA 510(k) clearance for KARL STORZ Flexible Video-Neuro-Endosco... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Neurology device (product code GWG) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K161112 · KARL STORZ Endoscopy-America, Inc. · Neurology device
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Sep 2016
Decision
150d
Days
Class 2
Risk

K161112 is an FDA 510(k) clearance for the KARL STORZ Flexible Video-Neuro-Endoscope System. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on September 17, 2016 after a review of 150 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K161112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2016
Decision Date September 17, 2016
Days to Decision 150 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
2d slower than avg
Panel avg: 148d · This submission: 150d
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 K161112.
Artemis Neuro Evacuation Device
K171332 · Penumbra, Inc. · Aug 2017
KARL STORZ ShuntScope
K170462 · KARL STORZ Endoscopy-America, Inc. · May 2017
TIPCAM 1S 3D System
K162880 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
Apollo System
K152699 · Penumbra, Inc. · Mar 2016
MINOP Disposable Introducer 26F
K142315 · Aesculap, Inc. · Nov 2014
APOLLO SYSTEM
K132931 · Penumbra, Inc. · Jan 2014