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Panels › Gastroenterology, Urology › Product code FBN · Class 2

Choledochoscope And Accessories, Flexible/Rigid

Regulation 876.1500

3510(k)s in 12 months (43 all time)
1recalls in 12 months (9 all time)
7recalls that name a 510(k)
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Top companies in FBN

Company510(k)sRecalls
Olympus Medical Systems Corp.60
Boston Scientific Corporation41
Olympus Corporation of the Americas04
KARL STORZ Endoscopy-America, Inc.30
Pentax Precision Instrument Corp.30
Applied Laparoscopy20
Mirco-Tech (Nanjing) Co., Ltd.20
Olympus Corp.20
Pentax Medical Company02
Richard Wolf Medical Instruments Corp.20
Decided510(k)Device and applicantCode
Apr 3, 2026K254153Single-use Video Scope; PB Digital Controller
Mirco-Tech (Nanjing) Co., Ltd., CN
FBN
Mar 19, 2026K253139Disposable Distal Cap
Mirco-Tech (Nanjing) Co., Ltd., CN
FBN
Jan 20, 2026K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endosc
Scivita Medical Technology Co., Ltd., CN
FBN
Sep 12, 2025K251170Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
Tangent Endoscopy, LLC
FBN
Mar 7, 2025K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
Shanghai SeeGen Photoelectric Technology Co., Ltd., CN
FBN
Jan 21, 2025K241444Biliary Pancreaticobiliary Scope System
Shenzhen HugeMed Medical Technical Development Co., Ltd., CN
FBN
May 2, 2024K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps
CenterPoint Systems, LLC
FBN
Mar 6, 2024K231497Choledochoscope System
Shenzhen HugeMed Medical Technical Development Co., Ltd., CN
FBN
Oct 17, 2023K231105Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
Shanghai AnQing Medical Instrument Co., Ltd., CN
FBN
Jun 22, 2023K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:
Zhuhai Pusen Medical Technology Co., Ltd., CN
FBN
Apr 20, 2023K222261Flexible Video-Choledochoscope System
Shanghai SeeGen Photoelectric Technology Co., Ltd., CN
FBN
Feb 16, 2023K221784Single-use Video Pancreaticobiliary Scope, PB Digital Controller
Micro-Tech (Nanjing) Co., Ltd., CN
FBN
May 21, 2020K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
Boston Scientific Corporation
FBN
Jan 22, 2019K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
Boston Scientific Corporation
FBN
Aug 23, 2018K181439SpyGlass DS and DS II Direct Visualization System
Boston Scientific Corporation
FBN
Jun 7, 2016K161147EndoCure Model EUR078A
Endocure Technologies, Inc.
FBN
Jan 16, 2015K142922SpyGlass DS Direct Visualization System
Boston Scientific Corporation
FBN
Sep 25, 2012K113120CHF-Y0005
Olympus Medical Systems Corp.
FBN
Mar 10, 2010K093507OLYMPUS CHF TYPE Y0003
Olympus Medical Systems Corporation
FBN
Nov 6, 2008K081456OLYMPUS CHF TYPE V
Olympus Medical Systems Corporation
FBN
Oct 21, 2008K082576XCHF-T160 VIDEOSCOPE
Olympus Medical Systems Corporation
FBN
May 6, 2008K080586OLYMPUS XCHF TYPE B180Y1
Olympus Medical Systems Corporation
FBN
Mar 31, 2006K060269ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
Acmi Corporation
FBN
Nov 14, 2005K051886OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
Olympus Medical Systems Corporation
FBN
Oct 8, 1997K972926MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
KARL STORZ Endoscopy-America, Inc.
FBN
Aug 12, 1997K971977KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
KARL STORZ Endoscopy-America, Inc.
FBN
Dec 2, 1996K962172FLEXIBLE MINI-FIBERSCOPES
Richard Wolf Medical Instruments Corp.
FBN
Nov 22, 1995K944473XCHF-33 CHOLEDOCHOFIBERSCOPE
Olympus America, Inc.
FBN
Nov 3, 1995K953286FCP-9P, FIBER CHOLEDOCHOSCOPE
Pentax Precision Instrument Corp.
FBN
May 30, 1995K951191FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
Pentax Precision Instrument Corp.
FBN
Feb 28, 1995K942112KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
Karl Storz Endoscopy
FBN
Jul 8, 1994K933906CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
Fujinon, Inc.
FBN
Mar 7, 1994K935834TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE
Technology Marketing Group
FBN
Jun 18, 1993K93138211274 AC FLEXINBLE CHOLEDOCHOSCOPE
KARL STORZ Endoscopy-America, Inc.
FBN
Feb 26, 1993K924228OMEGASCOPE
Omega Universal Technologies, Ltd.
FBN
Aug 21, 1992K920224DOSCOPE AND ACESSORIES
Applied Laparoscopy
FBN
Jan 30, 1992K915681CHOLEDOCHOSCOPE
Applied Laparoscopy
FBN
Aug 7, 1991K912120URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
Olympus Corp.
FBN
Jun 20, 1991K911480FLEXIBLE CHOLEDOCHOSCOPE
United States Endoscopy Group, Inc.
FBN
Mar 27, 1991K904799CHF-B20 CHOLEDOCHOSCOPE
Olympus Corp.
FBN
May 22, 1990K901010FLEXIBLE CHOLEDOCHOSCOPE
Intramed Laboratories, Inc.
FBN
Aug 10, 1982K821974PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
Pentax Precision Instrument Corp.
FBN
Aug 2, 1977K771367CHOLEDOCHOSCOPE SYSTEM
Richard Wolf Medical Instruments Corp.
FBN

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