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FDA 510(k)

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

K-Number: K191282 · 2019-11-08

ApplicantPentax of America, Inc.
Decision Date2019-11-08
Product CodePEA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191282. 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 Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Pentax of America, Inc.. The 510(k) number is K191282.

When did PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family receive FDA 510(k) clearance?

PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191282.

Who is the listed applicant for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

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

What is the FDA product code for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family?

The FDA product code for PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is PEA.

Other records listing Pentax of America, 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.

K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)K251127PENTAX Medical Video Processor (EPK-i8020c)K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

View all 39 devices →

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.K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax of America, Inc.K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, 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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