FDA 510(k) Applications Submitted by Shinichiro Kawachi

FDA 510(k) Number Submission Date Device Name Applicant
K250432 02/14/2025 Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) Olympus Medical Systems Corporation
K250701 03/07/2025 Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) Olympus Medical Systems Corp.
K221631 06/06/2022 Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V Olympus Medical Systems Corp.
K221638 06/06/2022 Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 Olympus Medical Systems Corp.
K221660 06/08/2022 RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP Olympus Medical Systems Corp.
K221683 06/10/2022 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) Olympus Medical Systems Corporation
K221690 06/10/2022 OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) Olympus Medical Systems Corp.
K241842 06/26/2024 Luer-Split MAJ-2092 Olympus Medical Systems Corporation
K242357 08/08/2024 Water Container (MAJ-901); Water Container (MAJ-902) Olympus Medical Systems Corporation
K222584 08/26/2022 EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 Olympus Medical Systems Corporation
K222861 09/22/2022 EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 Olympus Medical Systems Corporation
K232997 09/22/2023 EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 Olympus Medical Systems Corporation
K243527 11/14/2024 High Flow Insufflation Unit (UHI-4) Olympus Medical Systems Corporation


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