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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
DateFirm and productCodeLinked 510(k)
May 15, 2026TANGENT ENDOSCOPY, LLC
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Open, Classified		 FBNK251170
Jan 16, 2025Olympus Corporation of the Americas
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow bot
Open, Classified		 FBNK912120
Nov 17, 2023Aizu Olympus Co., Ltd.
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Numb
Open, Classified		 FBNK093507
Mar 31, 2022Olympus Corporation of the Americas
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Terminated		 FBNNone listed
Aug 31, 2020Olympus Corporation of the Americas
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for
Terminated		 FBNNone listed
Dec 20, 2017Boston Scientific Corporation
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Terminated		 FBNK142922
Dec 12, 2016Olympus Corporation of the Americas
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Terminated		 FBNK912120
Jun 28, 2016Pentax Medical Company
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bil
Terminated		 FBNK953286
Jun 28, 2016Pentax Medical Company
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems:
Terminated		 FBNK951191

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