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Olympus Medical Systems Corporation

FDA 510(k) & PMA Approved Devices — 86 products

Total Devices86
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K260401 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)PSV2026-08-27 View
510(k) K260824 Gastrointestinal Videoscope Olympus GIF-2T1500FDS2026-08-27 View
510(k) K260856 Disposable Distal Attachment D-201-13404FDS2026-08-27 View
510(k) K261183 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG2026-07-31 View
510(k) K261260 HD Camera Head OLYMPUS CH-S200-08-LBFET2026-06-24 View
510(k) K252050 Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB2026-03-20 View
510(k) K250993 Single Use Cytology Brush V (BC-V600P-3010)FDX2025-12-18 View
510(k) K252889 Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS2025-11-25 View
510(k) K250409 Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)FGE2025-10-21 View
510(k) K252247 Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)FBK2025-10-16 View
510(k) K250351 Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)KNS2025-10-10 View
510(k) K250187 Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)KGE2025-10-07 View
510(k) K252150 Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)GEI2025-10-07 View
510(k) K251859 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG2025-10-03 View
510(k) K251986 AUXILIARY WATER TUBE MAJ-855OCX2025-09-26 View
510(k) K251997 Single-Use Biopsy Valve (MAJ-1555)OCX2025-09-25 View
510(k) K250883 ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)ITX2025-09-18 View
510(k) K251664 Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)KTI2025-07-29 View
510(k) K250949 Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)ODC2025-07-16 View
510(k) K250762 ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)ITX2025-07-11 View
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