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FDA 510(k)

KARL STORZ ShuntScope

K-Number: K170462 · 2017-05-16

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2017-05-16
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KARL STORZ ShuntScope is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2017-05-16 under approval number K170462. 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 ShuntScope?

KARL STORZ ShuntScope is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K170462.

When was KARL STORZ ShuntScope approved by the FDA?

KARL STORZ ShuntScope received FDA 510(k) clearance on 2017-05-16, under approval number K170462.

What company makes KARL STORZ ShuntScope?

KARL STORZ ShuntScope is manufactured by KARL STORZ Endoscopy-America, Inc..

What is the FDA product code for KARL STORZ ShuntScope?

The FDA product code for KARL STORZ ShuntScope is GWG.

Other Devices by KARL STORZ Endoscopy-America, Inc.

K161112KARL STORZ Flexible Video-Neuro-Endoscope System K152583KARL STORZ Endoscopic ICG Imaging System K171717AUTOCON III 400 K171238KARL STORZ ICG Imaging System K161554ENDOFLATOR 40, ENDOFLATOR 50 K162882KARL STORZ ICG Imaging System

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Related Devices (Code: GWG)

K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. K152699Apollo SystemPenumbra, Inc. K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG K171332Artemis Neuro Evacuation DevicePenumbra, 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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