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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 a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-11-08 under approval 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. It is manufactured by Pentax of America, Inc.. The 510(k) number is K191282.

When was PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family approved by the FDA?

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

What company makes 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 manufactured by Pentax of America, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 39964125 Potential health benefits of lactoferrin and derived peptides - how to qualify as a medical device? Critical reviews in microbiology (2025) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Pentax of America, Inc.

K162151PENTAX Medical ENT Video Imaging System K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner K182004PENTAX Medical Endoscopic Ultrasound System K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

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Related Devices (Code: PEA)

K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc. K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPentax 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. K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cLPentax of America, Inc. K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax 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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