Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PENTAX MEDICAL ED-3490TK, Video Duodenoscope

K-Number: K161222 · 2018-02-07

ApplicantPentax Medical
Decision Date2018-02-07
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX MEDICAL ED-3490TK, Video Duodenoscope is a medical device manufactured by Pentax Medical. It received FDA 510(k) clearance on 2018-02-07 under approval number K161222. 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 ED-3490TK, Video Duodenoscope?

PENTAX MEDICAL ED-3490TK, Video Duodenoscope is a medical device that received FDA 510(k) clearance on 2018-02-07. It is manufactured by Pentax Medical. The 510(k) number is K161222.

When was PENTAX MEDICAL ED-3490TK, Video Duodenoscope approved by the FDA?

PENTAX MEDICAL ED-3490TK, Video Duodenoscope received FDA 510(k) clearance on 2018-02-07, under approval number K161222.

What company makes PENTAX MEDICAL ED-3490TK, Video Duodenoscope?

PENTAX MEDICAL ED-3490TK, Video Duodenoscope is manufactured by Pentax Medical.

What is the FDA product code for PENTAX MEDICAL ED-3490TK, Video Duodenoscope?

The FDA product code for PENTAX MEDICAL ED-3490TK, 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

K163614PENTAX Medical ED34-i10T, Video Duodenoscope K171011PENTAX Medical VIVIDEO ENT Videoscope Solution K172156PENTAX Medical EPK-3000 Video Imaging System K192280PENTAX Medical ED-3490TK Video Duodenoscope

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. 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.

↑