FDA 510(k) Applications for Medical Device Product Code "ODG"
(Endoscopic Ultrasound System, Gastroenterology-Urology)

FDA 510(k) Number Applicant Device Name Decision Date
K163058 BOSTON SCIENTIFIC Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle 01/30/2017
K173184 Boston Scientific Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle 10/27/2017
K110030 BOSTON SCIENTIFIC CORP. EXPECT ENDOSCOPIC ASPIRATION NEEDLE 01/12/2011
K160845 BOSTON SCIENTIFIC CORPORATION Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device 05/03/2016
K112198 Boston Scientific Corporation EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE 09/14/2011
K133312 Boston Scientific Corporation EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE 01/03/2014
K183433 Fujifilm Corporation FUJIFILM Ultrasonic Endoscope 09/05/2019
K171207 FUJIFILM Medical Systems U.S.A., Inc. FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M 01/11/2018
K172309 Micro-Tech (Nanjing) CO.,Ltd. Endoscopic Ultrasound Aspiration Needle 09/29/2017
K011886 OLYMPUS AMERICA, INC. OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, 08/27/2001
K961048 OLYMPUS AMERICA, INC. OLYMPUS MH-246R BALLOON SHEATH 09/16/1996
K042140 OLYMPUS CORPORATION OLYMPUS BF TYPE UC160-OL8 08/18/2004
K010591 OLYMPUS OPTICAL CO., LTD. OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER 03/15/2001
K031347 OLYMPUS OPTICAL CO., LTD. ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 05/09/2003
K061068 PENTAX MEDICAL COMPANY EG-3670URK 05/03/2006
K090196 PENTAX MEDICAL COMPANY EG-3670URK 05/19/2009
K090197 PENTAX MEDICAL COMPANY EG-3870UTK 05/19/2009
K130206 PENTAX OF AMERICA, INC. PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS 03/20/2013
K130247 PENTAX OF AMERICA, INC. PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS 03/20/2013
K182004 PENTAX of America, Inc. PENTAX Medical Endoscopic Ultrasound System 08/21/2018
K162447 PENTAX of America, Inc. PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner 04/13/2017
K021278 PENTAX PRECISION INSTRUMENT CORP. EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE 09/06/2002
K023401 PENTAX PRECISION INSTRUMENT CORP. EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE 02/11/2003
K031789 PENTAX PRECISION INSTRUMENT CORP. EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE 08/08/2003
K021276 PENTAX PRECISION INSTRUMENT CORP. FG-36UX FIBER ULTRASOUND GASTROSCOPE 09/12/2002
K010740 PENTAX PRECISION INSTRUMENT CORP. FG-36UX, FIBER ULTRASOUND GASTROSCOPE 04/17/2001
K982734 THE OLYMPUS OPTICAL CO. OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE 10/05/1998
K180731 United States Endoscopy Group, Inc. (US Endoscopy) Ultramatrix EUS Balloon 04/19/2018


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