Olympus Medical Systems Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
100
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LRMarch 6, 2026
K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)February 22, 2026
K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source OlymNovember 12, 2025
K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)October 24, 2025
K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use SphincterotOctober 17, 2025
K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)September 19, 2025
K250862EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P1June 23, 2025
K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)June 5, 2025
K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula May 27, 2025
K250296Disposable Distal Attachment D-201 SeriesMay 1, 2025
K250263Disposable Grasping Forceps FG-52D/FG-54DMarch 31, 2025
K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432PMarch 18, 2025
K240617Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long ClipJune 3, 2024
K221690OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDEDecember 29, 2022
K221660RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XPDecember 28, 2022
K221631Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type VSeptember 26, 2022
K221638Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3September 19, 2022
K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190VMay 11, 2022
K2200694K UHD LCD Monitor OEV321UHMarch 9, 2022
K212667Single Use Guide Sheath Kit-401, K-402September 22, 2021