FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K060269 |
ACMI CORPORATION |
ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM |
03/31/2006 |
K200483 |
Boston Scientific Corporation |
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller |
05/21/2020 |
K181439 |
Boston Scientific Corporation |
SpyGlass DS and DS II Direct Visualization System |
08/23/2018 |
K142922 |
BOSTON SCIENTIFIC CORPORATION |
SpyGlass DS Direct Visualization System |
01/16/2015 |
K183636 |
Boston Scientific Corporation |
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller |
01/22/2019 |
K161147 |
ENDOCURE TECHNOLOGIES, INC. |
EndoCure Model EUR078A |
06/07/2016 |
K971977 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE |
08/12/1997 |
K972926 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE |
10/08/1997 |
K221784 |
Micro-Tech (Nanjing) Co., Ltd |
Single-use Video Pancreaticobiliary Scope, PB Digital Controller |
02/16/2023 |
K113120 |
OLYMPUS MEDICAL SYSTEMS CORP. |
CHF-Y0005 |
09/25/2012 |
K081456 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
OLYMPUS CHF TYPE V |
11/06/2008 |
K093507 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
OLYMPUS CHF TYPE Y0003 |
03/10/2010 |
K051886 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F |
11/14/2005 |
K080586 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
OLYMPUS XCHF TYPE B180Y1 |
05/06/2008 |
K082576 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
XCHF-T160 VIDEOSCOPE |
10/21/2008 |
K962172 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
FLEXIBLE MINI-FIBERSCOPES |
12/02/1996 |
K222261 |
Shanghai SeeGen Photoelectric Technology Co., Ltd |
Flexible Video-Choledochoscope System |
04/20/2023 |
K223741 |
Zhuhai Pusen Medical Technology Co., Ltd. |
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) |
06/22/2023 |