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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 the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) 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. The listed applicant is Endochoice, Inc.. The 510(k) number is K160275.

When did Fuse Endoscopic System with FuseBox Processor receive FDA 510(k) clearance?

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

Who is the listed applicant for Fuse Endoscopic System with FuseBox Processor?

The FDA 510(k) record lists Endochoice, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Endochoice, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: PEA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax of America, Inc.K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cLPentax of America, Inc.K191282PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI FamilyPentax of America, Inc.K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, 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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