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FDA 510(k)

PENTAX Medical ED34-i10T, Video Duodenoscope

K-Number: K163614 · 2017-09-20

ApplicantPentax Medical
Decision Date2017-09-20
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical ED34-i10T, Video Duodenoscope is a medical device manufactured by Pentax Medical. It received FDA 510(k) clearance on 2017-09-20 under approval number K163614. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical ED34-i10T, Video Duodenoscope?

PENTAX Medical ED34-i10T, Video Duodenoscope is a medical device that received FDA 510(k) clearance on 2017-09-20. It is manufactured by Pentax Medical. The 510(k) number is K163614.

When was PENTAX Medical ED34-i10T, Video Duodenoscope approved by the FDA?

PENTAX Medical ED34-i10T, Video Duodenoscope received FDA 510(k) clearance on 2017-09-20, under approval number K163614.

What company makes PENTAX Medical ED34-i10T, Video Duodenoscope?

PENTAX Medical ED34-i10T, Video Duodenoscope is manufactured by Pentax Medical.

What is the FDA product code for PENTAX Medical ED34-i10T, Video Duodenoscope?

The FDA product code for PENTAX Medical ED34-i10T, Video Duodenoscope is FDT.

Related Clinical Trials

NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT07530731 Platforms Comparison Study - NIXOS-COMPARISON ENROLLING_BY_INVITATION NCT07568093 PARO-agitation-study RECRUITING NCT07280065 REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool RECRUITING NCT06473558 Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology NOT_YET_RECRUITING

Related PubMed Literature

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 Medical

K171011PENTAX Medical VIVIDEO ENT Videoscope Solution K172156PENTAX Medical EPK-3000 Video Imaging System K161222PENTAX MEDICAL ED-3490TK, Video Duodenoscope K192280PENTAX Medical ED-3490TK Video Duodenoscope

Related Devices (Code: FDT)

K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180VOlympus Medical Systems Corp. K152257Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. K182051FUJIFILM Duodenoscope ModelFujifilm Corporation K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePentax of America, Inc. K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation

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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