Olympus Optical Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 22
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | October 16, 2003 |
| K031305 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | September 23, 2003 |
| K031648 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | July 24, 2003 |
| K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | July 16, 2003 |
| K031347 | ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 | May 9, 2003 |
| K024138 | HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE | March 12, 2003 |
| K021852 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES | February 11, 2003 |
| K022445 | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V | January 24, 2003 |
| K024033 | XTJF-160AF DUODENOVIDEOSCOPE | December 20, 2002 |
| K023280 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES | December 19, 2002 |
| K013759 | MSS-28CS-301/701 NEEDLESCOPE | August 20, 2002 |
| K022270 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | August 14, 2002 |
| K021179 | DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A | July 5, 2002 |
| K014166 | UHI-3 HIGH FLOW INSUFFLATION UNIT | June 25, 2002 |
| K021886 | OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE | June 19, 2002 |
| K021204 | OLYMPUS BF TYPE UM40 | May 1, 2002 |
| K013617 | LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS | January 30, 2002 |
| K013591 | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT | December 26, 2001 |
| K011484 | OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 | August 10, 2001 |
| K010591 | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER | March 15, 2001 |