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FDA 510(k)

PENTAX Medical ED-3490TK Video Duodenoscope

K-Number: K192280 · 2019-10-21

ApplicantPentax Medical
Decision Date2019-10-21
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 2019-10-21 under approval number K192280. 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 2019-10-21. It is manufactured by Pentax Medical. The 510(k) number is K192280.

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

PENTAX Medical ED-3490TK Video Duodenoscope received FDA 510(k) clearance on 2019-10-21, under approval number K192280.

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.

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Other Devices by Pentax Medical

K163614PENTAX Medical ED34-i10T, Video Duodenoscope K171011PENTAX Medical VIVIDEO ENT Videoscope Solution K172156PENTAX Medical EPK-3000 Video Imaging System K161222PENTAX 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. 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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