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FDA 510(k)

Image1 SPIES System

K-Number: K160044 · 2016-02-01

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2016-02-01
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Image1 SPIES System is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2016-02-01 under approval number K160044. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Image1 SPIES System?

Image1 SPIES System is a medical device that received FDA 510(k) clearance on 2016-02-01. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K160044.

When was Image1 SPIES System approved by the FDA?

Image1 SPIES System received FDA 510(k) clearance on 2016-02-01, under approval number K160044.

What company makes Image1 SPIES System?

Image1 SPIES System is manufactured by Karl Storz Endoscopy America, Inc..

What is the FDA product code for Image1 SPIES System?

The FDA product code for Image1 SPIES System is FET.

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Related Devices (Code: FET)

K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments Corporation K180414EPX-4440FN Digital Video Processor with Light SourceFujifilm New Development U.S.A., 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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