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FDA 510(k)

Fuse Endoscopic System with FuseBox Processor

K-Number: K160275 · 2016-08-01

ApplicantEndochoice, Inc.
Decision Date2016-08-01
Product CodePEA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fuse Endoscopic System with FuseBox Processor is a medical device manufactured by Endochoice, Inc.. It received FDA 510(k) clearance on 2016-08-01 under approval number K160275. The device is classified under product code PEA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fuse Endoscopic System with FuseBox Processor?

Fuse Endoscopic System with FuseBox Processor is a medical device that received FDA 510(k) clearance on 2016-08-01. It is manufactured by Endochoice, Inc.. The 510(k) number is K160275.

When was Fuse Endoscopic System with FuseBox Processor approved by the FDA?

Fuse Endoscopic System with FuseBox Processor received FDA 510(k) clearance on 2016-08-01, under approval number K160275.

What company makes Fuse Endoscopic System with FuseBox Processor?

Fuse Endoscopic System with FuseBox Processor is manufactured by Endochoice, Inc..

What is the FDA product code for Fuse Endoscopic System with FuseBox Processor?

The FDA product code for Fuse Endoscopic System with FuseBox Processor is PEA.

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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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