FDA 510(k) Applications Submitted by Olympus Medical Systems Corp.

FDA 510(k) Number Submission Date Device Name Applicant
K130058 01/09/2013 ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 OLYMPUS MEDICAL SYSTEMS CORP.
K131780 06/17/2013 EVIS EXERA III VIDEO SYSTEM OLYMPUS MEDICAL SYSTEMS CORP.
K142680 09/19/2014 ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT OLYMPUS MEDICAL SYSTEMS CORP.
K123421 11/06/2012 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORP.
K123704 12/03/2012 AUTOMATED ENDOSCOPE LEAK TESTER OLYMPUS MEDICAL SYSTEMS CORP.
K134026 12/30/2013 ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT OLYMPUS MEDICAL SYSTEMS CORP.
K132703 08/29/2013 THUNDERBEAT OLYMPUS MEDICAL SYSTEMS CORP.
K121701 06/08/2012 SYSTEMS INTEGRATION OLYMPUS MEDICAL SYSTEMS CORP.
K120357 02/06/2012 ENDOSCOPE REPROCESSOR OER-MINI OLYMPUS MEDICAL SYSTEMS CORP.
K121564 05/29/2012 ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 OLYMPUS MEDICAL SYSTEMS CORP.
K121959 07/05/2012 EVIS EXERA III VIDEO SYSTEM OLYMPUS MEDICAL SYSTEMS CORP.
K250263 01/29/2025 Disposable Grasping Forceps FG-52D/FG-54D Olympus Medical Systems Corp.
K250296 01/31/2025 Disposable Distal Attachment D-201 Series Olympus Medical Systems Corp.
K250573 02/26/2025 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.
K240617 03/05/2024 Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) Olympus Medical Systems Corp.
K243807 12/11/2024 Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P Olympus Medical Systems Corp.
K120278 01/30/2012 WIRELESS IMAGE TRANSMITTER UNIT OLYMPUS MEDICAL SYSTEMS CORP.
K111425 05/23/2011 OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 OLYMPUS MEDICAL SYSTEMS CORP.
K122505 08/16/2012 SINGLE USE PRELOADED SPHINCTEROTOME V OLYMPUS MEDICAL SYSTEMS CORP.
K113120 10/21/2011 CHF-Y0005 OLYMPUS MEDICAL SYSTEMS CORP.
K143303 11/18/2014 Single Use Biliary Balloon Dilator OLYMPUS MEDICAL SYSTEMS CORP.
K122831 09/17/2012 VIDEO SYSTEM CENTER OLYMPUS MEDICAL SYSTEMS CORP.
K123365 10/31/2012 OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 OLYMPUS MEDICAL SYSTEMS CORP.
K123601 11/21/2012 SINGLE USE REPOSITIONABLE CLIP OLYMPUS MEDICAL SYSTEMS CORP.
K250701 03/07/2025 Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) Olympus Medical Systems Corp.
K221638 06/06/2022 Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 Olympus Medical Systems Corp.
K221631 06/06/2022 Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V Olympus Medical Systems Corp.
K221660 06/08/2022 RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP Olympus Medical Systems Corp.
K221690 06/10/2022 OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) Olympus Medical Systems Corp.
K111756 06/22/2011 V1 SYSTEM OLYMPUS MEDICAL SYSTEMS CORP.
K111202 04/29/2011 SURGICAL TISSUE MANAGEMENT SYSTEM OLYMPUS MEDICAL SYSTEMS CORP.
K250862 03/21/2025 EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) Olympus Medical Systems Corp.
K220587 03/01/2022 Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp.
K150142 01/22/2015 Single Use Balloon Dilator V (with Knife) OLYMPUS MEDICAL SYSTEMS CORP.
K220069 01/10/2022 4K UHD LCD Monitor OEV321UH Olympus Medical Systems Corp.
K160098 01/19/2016 Single Use Aspiration Needle NA-U401SX OLYMPUS MEDICAL SYSTEMS CORP.
K160241 02/01/2016 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 OLYMPUS MEDICAL SYSTEMS CORP.
K190239 02/06/2019 Single Use Aspiration Needle Olympus Medical Systems Corp.
K190293 02/11/2019 Single Use Cytology Brush BC-205D Olympus Medical Systems Corp.
K200342 02/11/2020 Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L Olympus Medical Systems Corp.
K200397 02/18/2020 Single Use Biopsy Forceps FB-456D Olympus Medical Systems Corp.
K180449 02/20/2018 Single Use Aspiration Needle NA-U200H Olympus Medical Systems Corp.
K190449 02/25/2019 Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head Olympus Medical Systems Corp.
K200542 03/03/2020 Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head Olympus Medical Systems Corp.
K180575 03/05/2018 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X Olympus Medical Systems Corp.
K180668 03/14/2018 Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N Olympus Medical Systems Corp.
K170811 03/17/2017 Single Use Retrieval Nitinol Basket V OLYMPUS MEDICAL SYSTEMS CORP.
K190772 03/26/2019 SURGICAL MICROSCOPE SYSTEM ORBEYE with IR OLYMPUS MEDICAL SYSTEMS CORP.
K190969 04/12/2019 ENDOSCOPE REPROCESSOR OER-Elite Olympus Medical Systems Corp.
K151011 04/15/2015 VISERA 4K UHD SYSTEM Olympus Medical Systems Corp.
K171158 04/20/2017 Single Use Electrosurgical knife Olympus Medical Systems Corp.
K201200 05/04/2020 Visera Elite II Video System Center Olympus Medical Systems Corp.
K181240 05/10/2018 Rhino-Laryngo Fiberscope Olympus ENF-GP2 Olympus Medical Systems Corp.
K201300 05/15/2020 Airway Mobilescope Olympus Medical Systems Corp.
K181451 06/01/2018 URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R Olympus Medical Systems Corp.
K151738 06/26/2015 Single Use Aspiration Needle NA-U200H OLYMPUS MEDICAL SYSTEMS CORP.
K171916 06/26/2017 Single Use Hot Biopsy Forceps FD-231 Olympus Medical Systems Corp.
K151743 06/29/2015 THUNDERBEAT Open Fine Jaw OLYMPUS MEDICAL SYSTEMS CORP.
K201758 06/29/2020 EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 Olympus Medical Systems Corp.
K201832 07/02/2020 Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 Olympus Medical Systems Corp.
K201920 07/10/2020 Endoscope Reprocessor OER-Elite Olympus Medical Systems Corp.
K172246 07/26/2017 OLYMPUS URF-V2/V2R Olympus Medical Systems Corp.
K181994 07/26/2018 Single Use Aspiration Needle NA-U201H Olympus Medical Systems Corp.
K172298 07/31/2017 OLYMPUS URF-P6/P6R Olympus Medical Systems Corp.
K182102 08/03/2018 RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 Olympus Medical Systems Corp.
K192103 08/05/2019 Thunderbeat Open Fine Jaw Type X Hand Instrument Olympus Medical Systems Corp.
K192164 08/09/2019 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR Olympus Medical Systems Corp.
K212667 08/23/2021 Single Use Guide Sheath Kit-401, K-402 Olympus Medical Systems Corp.
K172610 08/31/2017 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S Olympus Medical Systems Corp.
K172618 08/31/2017 SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 OLYMPUS MEDICAL SYSTEMS CORP.
K182408 09/04/2018 Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 Olympus Medical Systems Corp.
K172691 09/06/2017 Ultrasonic Generator OLYMPUS MEDICAL SYSTEMS CORP.
K172734 09/11/2017 Single Use Electrosurgical Snare SD-400 Olympus Medical Systems Corp.
K172726 09/11/2017 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D Olympus Medical Systems Corp.
K192498 09/11/2019 Single Use Injector Olympus Medical Systems Corp.
K202646 09/11/2020 Visera Elite II Video System Center Olympus Medical Systems Corp.
K202661 09/14/2020 Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp.
K172817 09/18/2017 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA Olympus Medical Systems Corp.
K192793 09/30/2019 Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I Olympus Medical Systems Corp.
K203128 10/19/2020 EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS Olympus Medical Systems Corp.
K193026 10/30/2019 Visera Elite II Video System Center, Visera Elite II Endoeye 3D Olympus Medical Systems Corp.
K193039 10/31/2019 Single Use Balloon Dilator V (with knife) Olympus Medical Systems Corp.
K163069 11/02/2016 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORP.
K183053 11/02/2018 Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp.
K143153 11/03/2014 EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V OLYMPUS MEDICAL SYSTEMS CORP.
K173459 11/07/2017 Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp.
K173495 11/13/2017 Single Use Hot Biopsy Forceps FD-231 Olympus Medical Systems Corp.
K193182 11/18/2019 Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp.
K183419 12/10/2018 EVIS EXERA III Bronchovideoscope Olympus BF-XT190 Olympus Medical Systems Corp.
K183416 12/10/2018 Rhino-Laryngo Videoscope Olympus ENF-VT3 Olympus Medical Systems Corp.
K153625 12/18/2015 Single Use Injector NM600/610 OLYMPUS MEDICAL SYSTEMS CORP.
K183525 12/19/2018 EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F Olympus Medical Systems Corp.
K183590 12/21/2018 Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip Olympus Medical Systems Corp.
K153773 12/31/2015 Disposal Lens Cleaning Sheath OLYMPUS MEDICAL SYSTEMS CORP.


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