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FDA 510(k)

Pentax Medical Video Duodenoscope ED34-i10T2

K-Number: K192245 · 2019-11-15

ApplicantPentax of America, Inc.
Decision Date2019-11-15
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pentax Medical Video Duodenoscope ED34-i10T2 is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-11-15 under approval number K192245. 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 Video Duodenoscope ED34-i10T2?

Pentax Medical Video Duodenoscope ED34-i10T2 is a medical device that received FDA 510(k) clearance on 2019-11-15. It is manufactured by Pentax of America, Inc.. The 510(k) number is K192245.

When was Pentax Medical Video Duodenoscope ED34-i10T2 approved by the FDA?

Pentax Medical Video Duodenoscope ED34-i10T2 received FDA 510(k) clearance on 2019-11-15, under approval number K192245.

What company makes Pentax Medical Video Duodenoscope ED34-i10T2?

Pentax Medical Video Duodenoscope ED34-i10T2 is manufactured by Pentax of America, Inc..

What is the FDA product code for Pentax Medical Video Duodenoscope ED34-i10T2?

The FDA product code for Pentax Medical Video Duodenoscope ED34-i10T2 is FDT.

Related Clinical Trials

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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 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: FDT)

K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180VOlympus Medical Systems Corp. K163614PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical 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

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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