FDA 510(k) Applications Submitted by Olympus Medical Systems Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K122180 07/23/2012 HIGH FLOW INSUFFLANTION UNIT OLYMPUS MEDICAL SYSTEMS CORPORATION
K050503 02/28/2005 SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 OLYMPUS MEDICAL SYSTEMS CORPORATION
K080403 02/14/2008 XTJF TYPE Q160VF1 OLYMPUS MEDICAL SYSTEMS CORPORATION
K050220 01/31/2005 EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC OLYMPUS MEDICAL SYSTEMS CORPORATION
K060243 01/31/2006 OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 OLYMPUS MEDICAL SYSTEMS CORPORATION
K060475 02/23/2006 EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 OLYMPUS MEDICAL SYSTEMS CORPORATION
K080581 03/03/2008 VB IMAGE VIEWER OLYMPUS MEDICAL SYSTEMS CORPORATION
K080586 03/03/2008 OLYMPUS XCHF TYPE B180Y1 OLYMPUS MEDICAL SYSTEMS CORPORATION
K080948 04/03/2008 HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH OLYMPUS MEDICAL SYSTEMS CORPORATION
K070983 04/06/2007 OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K050885 04/07/2005 OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG OLYMPUS MEDICAL SYSTEMS CORPORATION
K081173 04/24/2008 ENDOSCOPIC CO2 REGULATION UNIT UCR OLYMPUS MEDICAL SYSTEMS CORPORATION
K071254 05/04/2007 SMALL INTESTINAL VIDEOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K061313 05/10/2006 EVIS EXERA 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K081456 05/23/2008 OLYMPUS CHF TYPE V OLYMPUS MEDICAL SYSTEMS CORPORATION
K051551 06/13/2005 SMALL INTESTINAL VIDEOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K051613 06/17/2005 MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 OLYMPUS MEDICAL SYSTEMS CORPORATION
K051645 06/20/2005 EVIS EXERA 160A SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K051886 07/12/2005 OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F OLYMPUS MEDICAL SYSTEMS CORPORATION
K062049 07/20/2006 EVIS EXERA II 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K062517 08/28/2006 ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES OLYMPUS MEDICAL SYSTEMS CORPORATION
K052452 09/06/2005 VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT OLYMPUS MEDICAL SYSTEMS CORPORATION
K093106 10/01/2009 ENDOSCOPE REPROCESSOR OER-PRO OLYMPUS MEDICAL SYSTEMS CORPORATION
K072957 10/19/2007 EVIS EXERA II 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K063259 10/30/2006 OLYMPUS CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K093395 10/30/2009 OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION
K043275 11/26/2004 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER OLYMPUS MEDICAL SYSTEMS CORPORATION
K063683 12/12/2006 OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION
K063786 12/21/2006 ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 OLYMPUS MEDICAL SYSTEMS CORPORATION
K123317 10/25/2012 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N OLYMPUS MEDICAL SYSTEMS CORPORATION
K221683 06/10/2022 CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) Olympus Medical Systems Corporation
K222584 08/26/2022 EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 Olympus Medical Systems Corporation
K222861 09/22/2022 EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 Olympus Medical Systems Corporation
K091495 05/20/2009 SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A OLYMPUS MEDICAL SYSTEMS CORPORATION
K102763 09/24/2010 SYSTEMS INTEGRATION OLYMPUS MEDICAL SYSTEMS CORPORATION
K090210 01/28/2009 MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K110294 02/01/2011 HIGH FLOW INSUFFLATION UNIT UHI-4 OLYMPUS MEDICAL SYSTEMS CORPORATION
K091759 06/16/2009 SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H OLYMPUS MEDICAL SYSTEMS CORPORATION
K102059 07/22/2010 AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 OLYMPUS MEDICAL SYSTEMS CORPORATION
K092309 07/30/2009 SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L OLYMPUS MEDICAL SYSTEMS CORPORATION
K112680 09/14/2011 EVIS EXERA III VIDEO SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K082720 09/17/2008 TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005 OLYMPUS MEDICAL SYSTEMS CORPORATION
K093507 11/13/2009 OLYMPUS CHF TYPE Y0003 OLYMPUS MEDICAL SYSTEMS CORPORATION
K103478 11/26/2010 SINGLE USE BILIARY DRAINAGE STENT V OLYMPUS MEDICAL SYSTEMS CORPORATION
K100345 02/05/2010 SYSTEMS INTEGRATION MODEL: ENDOALPHA OLYMPUS MEDICAL SYSTEMS CORPORATION
K103312 11/10/2010 UPD-Y0003 OLYMPUS MEDICAL SYSTEMS CORPORATION
K100584 03/02/2010 EVIS EXERAII 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION
K101053 04/15/2010 OLYMPUS CF TYPE Y0023-L, Y0023I OLYMPUS MEDICAL SYSTEMS CORPORATION
K082576 09/05/2008 XCHF-T160 VIDEOSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION
K083155 10/24/2008 HD CAMERA HEAD OTV-S7PROH-HD-L08E OLYMPUS MEDICAL SYSTEMS CORPORATION
K102379 08/23/2010 LTF-Y0009; MAJ-YOO41; XOEV-3D1 OLYMPUS MEDICAL SYSTEMS CORPORATION
K103264 11/04/2010 ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO OLYMPUS MEDICAL SYSTEMS CORPORATION
K221557 05/31/2022 Visera Hysterovideoscope Olympus HYF Type V Olympus Medical Systems Corporation
K211838 06/14/2021 Ultrasonic Bipolar Generator USG-410 with accessories Olympus Medical Systems Corporation
K053382 12/05/2005 LAPARO-THORACO VIDEOSCOPE XLTF-VAW OLYMPUS MEDICAL SYSTEMS CORPORATION


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