Atlas FDA

FBN

43 FDA 510(k) clearances · Product code

113 daysmedian time to decision
287 days90th percentile
43clearances measured

FDA profile

Official device name
Choledochoscope And Accessories, Flexible/Rigid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 158 · 2022: 283 · 2023: 105 · 2024: 107 · 2025: 119 · 2026: 191
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Single-use Video Scope; PB Digital Controller (K254153)Mirco-Tech (Nanjing) Co., Ltd.2026-04-03
Disposable Distal Cap (K253139)Mirco-Tech (Nanjing) Co., Ltd.2026-03-19
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) (K251338)Scivita Medical Technology Co., Ltd.2026-01-20
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller (K251170)Tangent Endoscopy, LLC2025-09-12
Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) (K243535)Shanghai SeeGen Photoelectric Technology Co., Ltd.2025-03-07
Biliary Pancreaticobiliary Scope System (K241444)Shenzhen HugeMed Medical Technical Development Co., Ltd.2025-01-21
Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps (K233752)CenterPoint Systems, LLC2024-05-02
Choledochoscope System (K231497)Shenzhen HugeMed Medical Technical Development Co., Ltd.2024-03-06
Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) (K231105)Shanghai AnQing Medical Instrument Co., Ltd.2023-10-17
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) (K223741)Zhuhai Pusen Medical Technology Co., Ltd.2023-06-22
Flexible Video-Choledochoscope System (K222261)Shanghai SeeGen Photoelectric Technology Co., Ltd.2023-04-20
Single-use Video Pancreaticobiliary Scope, PB Digital Controller (K221784)Micro-Tech (Nanjing) Co., Ltd.2023-02-16
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller (K200483)Boston Scientific Corporation2020-05-21
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller (K183636)Boston Scientific Corporation2019-01-22
SpyGlass DS and DS II Direct Visualization System (K181439)Boston Scientific Corporation2018-08-23
EndoCure Model EUR078A (K161147)Endocure Technologies, Inc.2016-06-07
SpyGlass DS Direct Visualization System (K142922)Boston Scientific Corporation2015-01-16
CHF-Y0005 (K113120)Olympus Medical Systems Corp.2012-09-25
OLYMPUS CHF TYPE Y0003 (K093507)Olympus Medical Systems Corporation2010-03-10
OLYMPUS CHF TYPE V (K081456)Olympus Medical Systems Corporation2008-11-06
XCHF-T160 VIDEOSCOPE (K082576)Olympus Medical Systems Corporation2008-10-21
OLYMPUS XCHF TYPE B180Y1 (K080586)Olympus Medical Systems Corporation2008-05-06
ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM (K060269)Acmi Corporation2006-03-31
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F (K051886)Olympus Medical Systems Corporation2005-11-14
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE (K972926)KARL STORZ Endoscopy-America, Inc.1997-10-08
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE (K971977)KARL STORZ Endoscopy-America, Inc.1997-08-12
FLEXIBLE MINI-FIBERSCOPES (K962172)Richard Wolf Medical Instruments Corp.1996-12-02
XCHF-33 CHOLEDOCHOFIBERSCOPE (K944473)Olympus America, Inc.1995-11-22
FCP-9P, FIBER CHOLEDOCHOSCOPE (K953286)Pentax Precision Instrument Corp.1995-11-03
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE (K951191)Pentax Precision Instrument Corp.1995-05-30
KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE (K942112)Karl Storz Endoscopy1995-02-28
CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION (K933906)Fujinon, Inc.1994-07-08
TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE (K935834)Technology Marketing Group1994-03-07
11274 AC FLEXINBLE CHOLEDOCHOSCOPE (K931382)KARL STORZ Endoscopy-America, Inc.1993-06-18
OMEGASCOPE (K924228)Omega Universal Technologies, Ltd.1993-02-26
DOSCOPE AND ACESSORIES (K920224)Applied Laparoscopy1992-08-21
CHOLEDOCHOSCOPE (K915681)Applied Laparoscopy1992-01-30
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE (K912120)Olympus Corp.1991-08-07
FLEXIBLE CHOLEDOCHOSCOPE (K911480)United States Endoscopy Group, Inc.1991-06-20
CHF-B20 CHOLEDOCHOSCOPE (K904799)Olympus Corp.1991-03-27
FLEXIBLE CHOLEDOCHOSCOPE (K901010)Intramed Laboratories, Inc.1990-05-22
PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A (K821974)Pentax Precision Instrument Corp.1982-08-10
CHOLEDOCHOSCOPE SYSTEM (K771367)Richard Wolf Medical Instruments Corp.1977-08-02

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