Olympus Medical Systems Corp.
FDA 510(k) & PMA Approved Devices — 79 products
Total Devices79
Categories29
Latest FDA decision2026-07-01
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | GEI | 2026-07-01 | View |
| 510(k) | K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | PKL | 2026-05-21 | View |
| 510(k) | K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | EOQ | 2026-04-23 | View |
| 510(k) | K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | KGE | 2026-03-06 | View |
| 510(k) | K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | FDT | 2026-02-22 | View |
| 510(k) | K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | OWN | 2025-11-12 | View |
| 510(k) | K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | FCG | 2025-10-24 | View |
| 510(k) | K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | KNS | 2025-10-17 | View |
| 510(k) | K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | FDT | 2025-09-19 | View |
| 510(k) | K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | EOQ | 2025-06-23 | View |
| 510(k) | K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | FDT | 2025-06-05 | View |
| 510(k) | K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | ODD | 2025-05-27 | View |
| 510(k) | K250296 | Disposable Distal Attachment D-201 Series | FDS | 2025-05-01 | View |
| 510(k) | K250263 | Disposable Grasping Forceps FG-52D/FG-54D | KTI | 2025-03-31 | View |
| 510(k) | K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | LQR | 2025-03-18 | View |
| 510(k) | K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | PKL | 2024-06-03 | View |
| 510(k) | K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) | FAJ | 2022-12-29 | View |
| 510(k) | K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | EOB | 2022-12-28 | View |
| 510(k) | K221631 | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V | EOQ | 2022-09-26 | View |
| 510(k) | K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | EOB | 2022-09-19 | View |
No matching devices.
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