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 |
K223616 |
Boston Scientific Corporation |
AcquireÖ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device |
12/30/2022 |
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 |
K221952 |
FUJIFILM Corporation |
Endoscope Model EG-580UT and Endoscope Model EG-580UR |
08/04/2022 |
K183433 |
Fujifilm Corporation |
FUJIFILM Ultrasonic Endoscope |
09/05/2019 |
K221238 |
FUJIFILM Corporation |
FUJIFILM Ultrasonic Endoscope EG-740UT |
08/19/2022 |
K214089 |
Fujifilm Corporation |
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 |
06/03/2022 |
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 |
K212852 |
Micro-Tech(Nanjing) Co., Ltd. |
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle |
12/06/2021 |
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 |
K200090 |
PENTAX of America, Inc. |
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) |
07/23/2020 |
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 |
K203166 |
PENTAX of America, Inc. |
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
12/30/2020 |
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 |