Company ยท JP
Olympus Medical Systems Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
190510(k) clearances (15 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 19 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 10 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 10 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 8 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 8 |
| GCJ | Laparoscope, General & Plastic Surgery | 8 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 |
| FCG | Biopsy Needle | 7 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 7 |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 7 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 6 |
| HET | Laparoscope, Gynecologic (And Accessories) | 6 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 6 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 5 |
| FEB | Accessories, Cleaning, For Endoscope | 5 |
| KGE | Forceps, Biopsy, Electric | 4 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | 4 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 4 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 3 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2026 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB Olympus Medical Systems Corp., JP | FET |
| Aug 27, 2026 | K260856 | Disposable Distal Attachment D-201-13404 Olympus Medical Systems Corporation, JP | FDS |
| Aug 27, 2026 | K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 Olympus Medical Systems Corporation, JP | FDS |
| Aug 27, 2026 | K260401 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) Olympus Medical Systems Corporation, JP | PSV |
| Jul 31, 2026 | K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) Olympus Medical Systems Corporation, JP | ODG |
| Jul 1, 2026 | K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (T Olympus Medical Systems Corp., JP | GEI |
| Jun 24, 2026 | K261260 | HD Camera Head OLYMPUS CH-S200-08-LB Olympus Medical Systems Corporation, JP | FET |
| May 21, 2026 | K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-61 Olympus Medical Systems Corp., JP | PKL |
| Apr 23, 2026 | K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III Olympus Medical Systems Corp., JP | EOQ |
| Mar 20, 2026 | K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D Olympus Medical Systems Corporation, JP | EOB |
| Mar 6, 2026 | K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR Olympus Medical Systems Corp., JP | KGE |
| Feb 22, 2026 | K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) Olympus Medical Systems Corp., JP | FDT |
| Dec 18, 2025 | K250993 | Single Use Cytology Brush V (BC-V600P-3010) Olympus Medical Systems Corporation, JP | FDX |
| Nov 25, 2025 | K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) Olympus Medical Systems Corporation, JP | KNS |
| Nov 12, 2025 | K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S7 Olympus Medical Systems Corp., JP | OWN |
| Oct 24, 2025 | K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) Olympus Medical Systems Corp., JP | FCG |
| Oct 21, 2025 | K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) Olympus Medical Systems Corporation, JP | FGE |
| Oct 17, 2025 | K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire G Olympus Medical Systems Corp., JP | KNS |
| Oct 16, 2025 | K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max S Olympus Medical Systems Corporation, JP | FBK |
| Oct 10, 2025 | K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurg Olympus Medical Systems Corporation, JP | KNS |
| Oct 7, 2025 | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mo Olympus Medical Systems Corporation, JP | GEI |
| Oct 7, 2025 | K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) Olympus Medical Systems Corporation, JP | KGE |
| Oct 3, 2025 | K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) Olympus Medical Systems Corporation, JP | ODG |
| Sep 26, 2025 | K251986 | AUXILIARY WATER TUBE MAJ-855 Olympus Medical Systems Corporation, JP | OCX |
| Sep 25, 2025 | K251997 | Single-Use Biopsy Valve (MAJ-1555) Olympus Medical Systems Corporation, JP | OCX |
| Sep 19, 2025 | K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) Olympus Medical Systems Corp., JP | FDT |
| Sep 18, 2025 | K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) Olympus Medical Systems Corporation, JP | ITX |
| Jul 29, 2025 | K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) Olympus Medical Systems Corporation, JP | KTI |
| Jul 16, 2025 | K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) Olympus Medical Systems Corporation, JP | ODC |
| Jul 11, 2025 | K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) Olympus Medical Systems Corporation, JP | ITX |
| Jun 23, 2025 | K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III Olympus Medical Systems Corp., JP | EOQ |
| Jun 12, 2025 | K251279 | Disposable Cytology Brush BC-202D/203D Series Olympus Medical Systems Corporation, JP | BTG |
| Jun 5, 2025 | K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) Olympus Medical Systems Corp., JP | FDT |
| Jun 4, 2025 | K250118 | Disposable Balloon Catheter B5-2C Olympus Medical Systems Corporation, JP | EOQ |
| May 30, 2025 | K250957 | Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposabl Olympus Medical Systems Corporation, JP | EOQ |
| May 27, 2025 | K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M Olympus Medical Systems Corp., JP | ODD |
| May 15, 2025 | K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) Olympus Medical Systems Corporation, JP | FDF |
| May 1, 2025 | K250296 | Disposable Distal Attachment D-201 Series Olympus Medical Systems Corp., JP | FDS |
| Mar 31, 2025 | K250263 | Disposable Grasping Forceps FG-52D/FG-54D Olympus Medical Systems Corp., JP | KTI |
| Mar 19, 2025 | K241842 | Luer-Split MAJ-2092 Olympus Medical Systems Corporation, JP | ODC |
| Mar 18, 2025 | K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P Olympus Medical Systems Corp., JP | LQR |
| Mar 3, 2025 | K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) Olympus Medical Systems Corporation, JP | EOB |
| Jan 17, 2025 | K243502 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) Olympus Medical Systems Corporation, JP | IYN |
| Jan 13, 2025 | K243527 | High Flow Insufflation Unit (UHI-4) Olympus Medical Systems Corporation, JP | HIF |
| Oct 7, 2024 | K242357 | Water Container (MAJ-901); Water Container (MAJ-902) Olympus Medical Systems Corporation, JP | OCX |
| Jul 3, 2024 | K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) Olympus Medical Systems Corporation, JP | FET |
| Jun 19, 2024 | K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 Olympus Medical Systems Corporation, JP | FDS |
| Jun 3, 2024 | K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-61 Olympus Medical Systems Corp., JP | PKL |
| Jun 15, 2023 | K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 Olympus Medical Systems Corporation, JP | EOQ |
| Apr 26, 2023 | K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS Olympus Medical Systems Corporation, JP | FET |
Newest 50 of 190.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||