FDA Product Code FBN: Choledochoscope And Accessories, Flexible/rigid
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).
Leading manufacturers include Olympus Medical Systems Corporation, Boston Scientific Corporation and Pentax Precision Instrument Corp..
43
Total
43
Cleared
146d
Avg days
1977
Since
43 devices
Cleared
Dec 02, 1996
FLEXIBLE MINI-FIBERSCOPES
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology
180d
Cleared
Nov 22, 1995
XCHF-33 CHOLEDOCHOFIBERSCOPE
Olympus America, Inc.
Gastroenterology & Urology
439d
Cleared
Nov 03, 1995
FCP-9P, FIBER CHOLEDOCHOSCOPE
Pentax Precision Instrument Corp.
Gastroenterology & Urology
113d
Cleared
May 30, 1995
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
Pentax Precision Instrument Corp.
Gastroenterology & Urology
75d
Cleared
Feb 28, 1995
KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
Karl Storz Endoscopy
Gastroenterology & Urology
302d
Cleared
Jun 18, 1993
11274 AC FLEXINBLE CHOLEDOCHOSCOPE
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
92d
Cleared
Aug 07, 1991
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
Olympus Corp.
Gastroenterology & Urology
85d
Cleared
Jun 20, 1991
FLEXIBLE CHOLEDOCHOSCOPE
United States Endoscopy Group, Inc.
Gastroenterology & Urology
77d
Cleared
Mar 27, 1991
CHF-B20 CHOLEDOCHOSCOPE
Olympus Corp.
Gastroenterology & Urology
154d
Cleared
Aug 10, 1982
PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
Pentax Precision Instrument Corp.
Gastroenterology & Urology
39d
Cleared
Aug 02, 1977
CHOLEDOCHOSCOPE SYSTEM
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology
8d