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FDA 510(k)

PENTAX EPK-I5010 VIDEO PROCESSOR

K-Number: K122470 · 2013-04-10

ApplicantPentax Medical
Decision Date2013-04-10
Product CodePEA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX EPK-I5010 VIDEO PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical. It received FDA 510(k) clearance on 2013-04-10 under 510(k) number K122470. 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 PENTAX EPK-I5010 VIDEO PROCESSOR?

PENTAX EPK-I5010 VIDEO PROCESSOR is a medical device that received FDA 510(k) clearance on 2013-04-10. The listed applicant is Pentax Medical. The 510(k) number is K122470.

When did PENTAX EPK-I5010 VIDEO PROCESSOR receive FDA 510(k) clearance?

PENTAX EPK-I5010 VIDEO PROCESSOR received FDA 510(k) clearance on 2013-04-10, under 510(k) number K122470.

Who is the listed applicant for PENTAX EPK-I5010 VIDEO PROCESSOR?

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

What is the FDA product code for PENTAX EPK-I5010 VIDEO PROCESSOR?

The FDA product code for PENTAX EPK-I5010 VIDEO PROCESSOR is PEA.

Related Clinical Trials

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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Other records listing Pentax Medical 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.

K192280PENTAX Medical ED-3490TK Video DuodenoscopeK171011PENTAX Medical VIVIDEO ENT Videoscope SolutionK172156PENTAX Medical EPK-3000 Video Imaging SystemK161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopeK163614PENTAX Medical ED34-i10T, Video Duodenoscope

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.K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.

Official Source

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

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