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-NumberDeviceDate
K033225EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENTOctober 16, 2003
K031305OLYMPUS ULTRASONIC SURGICAL SYSTEMSeptember 23, 2003
K031648VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VJuly 24, 2003
K032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEJuly 16, 2003
K031347ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8May 9, 2003
K024138HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECEMarch 12, 2003
K021852OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIESFebruary 11, 2003
K022445VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE VJanuary 24, 2003
K024033XTJF-160AF DUODENOVIDEOSCOPEDecember 20, 2002
K023280OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIESDecember 19, 2002
K013759MSS-28CS-301/701 NEEDLESCOPEAugust 20, 2002
K022270MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHAAugust 14, 2002
K021179DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545AJuly 5, 2002
K014166UHI-3 HIGH FLOW INSUFFLATION UNITJune 25, 2002
K021886OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPEJune 19, 2002
K021204OLYMPUS BF TYPE UM40May 1, 2002
K013617LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTSJanuary 30, 2002
K013591XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENTDecember 26, 2001
K011484OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1August 10, 2001
K010591OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTERMarch 15, 2001