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FDA 510(k)

KARL STORZ Flexible Video-Neuro-Endoscope System

K-Number: K161112 · 2016-09-17

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2016-09-17
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Flexible Video-Neuro-Endoscope System is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2016-09-17 under approval number K161112. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ Flexible Video-Neuro-Endoscope System?

KARL STORZ Flexible Video-Neuro-Endoscope System is a medical device that received FDA 510(k) clearance on 2016-09-17. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K161112.

When was KARL STORZ Flexible Video-Neuro-Endoscope System approved by the FDA?

KARL STORZ Flexible Video-Neuro-Endoscope System received FDA 510(k) clearance on 2016-09-17, under approval number K161112.

What company makes KARL STORZ Flexible Video-Neuro-Endoscope System?

KARL STORZ Flexible Video-Neuro-Endoscope System is manufactured by KARL STORZ Endoscopy-America, Inc..

What is the FDA product code for KARL STORZ Flexible Video-Neuro-Endoscope System?

The FDA product code for KARL STORZ Flexible Video-Neuro-Endoscope System is GWG.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by KARL STORZ Endoscopy-America, Inc.

K152583KARL STORZ Endoscopic ICG Imaging System K171717AUTOCON III 400 K171238KARL STORZ ICG Imaging System K170462KARL STORZ ShuntScope K161554ENDOFLATOR 40, ENDOFLATOR 50 K162882KARL STORZ ICG Imaging System

View all 21 devices →

Related Devices (Code: GWG)

K152699Apollo SystemPenumbra, Inc. K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG K171332Artemis Neuro Evacuation DevicePenumbra, Inc. K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. K162880TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. K181731MR Compatible Aspiration KitMri Interventions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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