Olympus Optical Co., Ltd.
Melville, NY, US
Olympus Optical Co., Ltd. appears in FDA device records in Melville, NY. FDA records list 48 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 48
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 48 510(k) clearances for Olympus Optical Co., Ltd. between 1996 and 2003. The busiest year on record is 2003, with 12. The most recent is 2003, with 12.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1998 | 8 |
| 1999 | 1 |
| 2000 | 6 |
| 2001 | 9 |
| 2002 | 11 |
| 2003 | 12 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | EOQ | Substantially Equivalent | |
| K032066 | SONOSURG SYSTEM | LFL | Substantially Equivalent | |
| K031305 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent | |
| K031648 | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V | EOB | Substantially Equivalent | |
| K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | FCL | Substantially Equivalent | |
| K031347 | ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 | ODG | Substantially Equivalent | |
| K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | KNS | Substantially Equivalent | |
| K024138 | HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE | GEI | Substantially Equivalent | |
| K021962 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent | |
| K021852 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES | GEI | Substantially Equivalent | |
| K023984 | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES | EOQ | Substantially Equivalent | |
| K022445 | VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V | HIH | Substantially Equivalent | |
| K023272 | DISPOSABLE ASPIRATION NEEDLE NA-200H | FCG | Substantially Equivalent | |
| K024033 | XTJF-160AF DUODENOVIDEOSCOPE | FDT | Substantially Equivalent | |
| K023280 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES | GEI | Substantially Equivalent | |
| K023767 | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES | GEI | Substantially Equivalent | |
| K013759 | MSS-28CS-301/701 NEEDLESCOPE | GWG | Substantially Equivalent | |
| K022270 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | ODA | Substantially Equivalent | |
| K021179 | DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A | OCY | Substantially Equivalent | |
| K014166 | UHI-3 HIGH FLOW INSUFFLATION UNIT | HIF | Substantially Equivalent | |
| K021886 | OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P | FDS | Substantially Equivalent | |
| K021204 | OLYMPUS BF TYPE UM40 | PSV | Substantially Equivalent | |
| K013617 | LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS | GCJ | Substantially Equivalent | |
| K013591 | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT | EOB | Substantially Equivalent | |
| K012074 | XBO1-824-18/19/20 BIOPSY FORCEPS | OCZ | Substantially Equivalent | |
| K012073 | OLYMPUS SPRAY CATHETER PW-6C-1 | EOQ | Substantially Equivalent | |
| K011484 | OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 | FBK | Substantially Equivalent | |
| K011869 | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT | EOB | Substantially Equivalent | |
| K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z | FDS | Substantially Equivalent | |
| K011149 | DISPOSABLE BENDING CANNULA PR-233Q | ODD | Substantially Equivalent | |
| K010591 | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER | ODG | Substantially Equivalent | |
| K002231 | LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT | FDS | Substantially Equivalent | |
| K002749 | ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D | FDF | Substantially Equivalent | |
| K000095 | OLYMPUS SONOSURG TROCAR XT3900 SYSTEM | LFL | Substantially Equivalent | |
| K001766 | OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE | FDS | Substantially Equivalent | |
| K001203 | OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT | ITX | Substantially Equivalent | |
| K001241 | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I | FDF | Substantially Equivalent | |
| K993041 | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT | FAJ | Substantially Equivalent | |
| K990687 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS | PKL | Substantially Equivalent | |
| K982610 | OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) | ITX | Substantially Equivalent | |
| K982733 | OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE | ITX | Substantially Equivalent | |
| K982133 | OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT | HRX | Substantially Equivalent | |
| K982734 | OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE | ODG | Substantially Equivalent | |
| K981993 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | ODA | Substantially Equivalent | |
| K971340 | OLYMPUS NEURO ENDOSCOPE | GWG | Substantially Equivalent | |
| K981543 | OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT | EOQ | Substantially Equivalent | |
| K972114 | OLYMPUS SONOSURG SYSTEM | LFL | Substantially Equivalent | |
| K962952 | OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) | LBK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HRXArthroscope
- FCGBiopsy Needle
- EOQBronchoscope (Flexible Or Rigid)
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FDTDuodenoscope And Accessories, Flexible/Rigid
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GWGEndoscope, Neurological
- ODAEndoscopic Central Control Unit
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology
- FCLForceps, Biopsy, Non-Electric
- FDSGastroscope And Accessories, Flexible/Rigid
- PKLHemostatic Metal Clip For The Gi Tract
- HIHHysteroscope (And Accessories)
- LFLInstrument, Ultrasonic Surgical
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- EOBNasopharyngoscope (Flexible Or Rigid)
- LBKNeurosurgical Ultrasonic Instruments
- ITXTransducer, Ultrasonic, Diagnostic
- PSVUltrasound Bronchoscope
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain