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

Olympus Medical Systems Corporation

FDA 510(k) & PMA Approved Devices — 33 products

Total Devices33
Categories22
Latest FDA decision2026-07-31
TypeNumberDevice NameCodeDateActions
510(k) K250432 Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)FDF2025-05-15 View
510(k) K241842 Luer-Split MAJ-2092ODC2025-03-19 View
510(k) K243380 VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)EOB2025-03-03 View
510(k) K243502 EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)IYN2025-01-17 View
510(k) K243527 High Flow Insufflation Unit (UHI-4)HIF2025-01-13 View
510(k) K242357 Water Container (MAJ-901); Water Container (MAJ-902)OCX2024-10-07 View
510(k) K241371 VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)FET2024-07-03 View
510(k) K232997 EVIS Exera III Gastrointestinal Videoscope GIF-1TH190FDS2024-06-19 View
510(k) K222861 EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100EOQ2023-06-15 View
510(k) K222584 EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100FET2023-04-26 View
510(k) K221683 CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)FAJ2023-01-20 View
510(k) K221557 Visera Hysterovideoscope Olympus HYF Type VHIH2022-09-02 View
510(k) K211838 Ultrasonic Bipolar Generator USG-410 with accessoriesLFL2021-08-04 View

Page 2 of 2

↑