Olympus Medical Systems Corp.
Olympus Medical Systems Corp. appears in FDA public data with 0 recalls, 103 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 1, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 103
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-act | July 1, 2026 |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip | May 21, 2026 |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H19 | April 23, 2026 |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | March 6, 2026 |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | February 22, 2026 |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olym | November 12, 2025 |
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | October 24, 2025 |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterot | October 17, 2025 |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | September 19, 2025 |
| K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P1 | June 23, 2025 |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | June 5, 2025 |
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula | May 27, 2025 |
| K250296 | Disposable Distal Attachment D-201 Series | May 1, 2025 |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | March 31, 2025 |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | March 18, 2025 |
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip | June 3, 2024 |
| K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE | December 29, 2022 |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | December 28, 2022 |
| K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | September 26, 2022 |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | September 19, 2022 |