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FDA 510(k)

EVIS Exera III Gastrointestinal Videoscope GIF-1TH190

K-Number: K232997 · 2024-06-19

ApplicantOlympus Medical Systems Corporation
Decision Date2024-06-19
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2024-06-19 under approval number K232997. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS Exera III Gastrointestinal Videoscope GIF-1TH190?

EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 is a medical device that received FDA 510(k) clearance on 2024-06-19. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K232997.

When was EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 approved by the FDA?

EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 received FDA 510(k) clearance on 2024-06-19, under approval number K232997.

What company makes EVIS Exera III Gastrointestinal Videoscope GIF-1TH190?

EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 is manufactured by Olympus Medical Systems Corporation.

What is the FDA product code for EVIS Exera III Gastrointestinal Videoscope GIF-1TH190?

The FDA product code for EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 is FDS.

Other Devices by Olympus Medical Systems Corporation

K211838Ultrasonic Bipolar Generator USG-410 with accessories K221557Visera Hysterovideoscope Olympus HYF Type V K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) K242357Water Container (MAJ-901); Water Container (MAJ-902)

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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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