Olympus Medical Systems Corporation
FDA 510(k) & PMA Approved Devices — 31 products
Total Devices31
Categories22
Latest Approval2026-03-20
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | EOB | 2026-03-20 | View |
| 510(k) | K250993 | Single Use Cytology Brush V (BC-V600P-3010) | FDX | 2025-12-18 | View |
| 510(k) | K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | KNS | 2025-11-25 | View |
| 510(k) | K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | FGE | 2025-10-21 | 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) | FBK | 2025-10-16 | 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) | KNS | 2025-10-10 | 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) | GEI | 2025-10-07 | View |
| 510(k) | K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | KGE | 2025-10-07 | View |
| 510(k) | K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | ODG | 2025-10-03 | View |
| 510(k) | K251986 | AUXILIARY WATER TUBE MAJ-855 | OCX | 2025-09-26 | View |
| 510(k) | K251997 | Single-Use Biopsy Valve (MAJ-1555) | OCX | 2025-09-25 | View |
| 510(k) | K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | ITX | 2025-09-18 | View |
| 510(k) | K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | KTI | 2025-07-29 | View |
| 510(k) | K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | ODC | 2025-07-16 | View |
| 510(k) | K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | ITX | 2025-07-11 | View |
| 510(k) | K251279 | Disposable Cytology Brush BC-202D/203D Series | BTG | 2025-06-12 | View |
| 510(k) | K250118 | Disposable Balloon Catheter B5-2C | EOQ | 2025-06-04 | View |
| 510(k) | K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) | EOQ | 2025-05-30 | View |
| 510(k) | K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | FDF | 2025-05-15 | View |
| 510(k) | K241842 | Luer-Split MAJ-2092 | ODC | 2025-03-19 | View |
| 510(k) | K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | EOB | 2025-03-03 | View |
| 510(k) | K243502 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | IYN | 2025-01-17 | View |
| 510(k) | K243527 | High Flow Insufflation Unit (UHI-4) | HIF | 2025-01-13 | View |
| 510(k) | K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | OCX | 2024-10-07 | View |
| 510(k) | K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | FET | 2024-07-03 | View |
| 510(k) | K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | FDS | 2024-06-19 | View |
| 510(k) | K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | EOQ | 2023-06-15 | View |
| 510(k) | K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | FET | 2023-04-26 | 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) | FAJ | 2023-01-20 | View |
| 510(k) | K221557 | Visera Hysterovideoscope Olympus HYF Type V | HIH | 2022-09-02 | View |
| 510(k) | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | LFL | 2021-08-04 | View |
No matching devices.