Olympus Medical Systems Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 80
- Inspections
- 2
- Compliance Actions
- 2
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | December 18, 2025 |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | November 25, 2025 |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Cathe | October 21, 2025 |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); | October 16, 2025 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Si | October 10, 2025 |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shear | October 7, 2025 |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | October 7, 2025 |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | October 3, 2025 |
| K251986 | AUXILIARY WATER TUBE MAJ-855 | September 26, 2025 |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | September 25, 2025 |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | September 18, 2025 |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | July 29, 2025 |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | July 16, 2025 |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | July 11, 2025 |
| K251279 | Disposable Cytology Brush BC-202D/203D Series | June 12, 2025 |
| K250118 | Disposable Balloon Catheter B5-2C | June 4, 2025 |
| K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps | May 30, 2025 |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1 | May 15, 2025 |
| K241842 | Luer-Split MAJ-2092 | March 19, 2025 |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | March 3, 2025 |