FBN · Class II · 21 CFR 876.1500

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
25–43 of 43
Cleared Oct 08, 1997
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
K972926
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 61d
Cleared Aug 12, 1997
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
K971977
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Dec 02, 1996
FLEXIBLE MINI-FIBERSCOPES
K962172
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 180d
Cleared Nov 22, 1995
XCHF-33 CHOLEDOCHOFIBERSCOPE
K944473
Olympus America, Inc.
Gastroenterology & Urology · 439d
Cleared Nov 03, 1995
FCP-9P, FIBER CHOLEDOCHOSCOPE
K953286
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 113d
Cleared May 30, 1995
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
K951191
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 75d
Cleared Feb 28, 1995
KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE
K942112
Karl Storz Endoscopy
Gastroenterology & Urology · 302d
Cleared Jul 08, 1994
CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
K933906
Fujinon, Inc.
Gastroenterology & Urology · 331d
Cleared Jun 18, 1993
11274 AC FLEXINBLE CHOLEDOCHOSCOPE
K931382
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 92d
Cleared Aug 07, 1991
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
K912120
Olympus Corp.
Gastroenterology & Urology · 85d
Cleared Jun 20, 1991
FLEXIBLE CHOLEDOCHOSCOPE
K911480
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 27, 1991
CHF-B20 CHOLEDOCHOSCOPE
K904799
Olympus Corp.
Gastroenterology & Urology · 154d
Cleared Aug 10, 1982
PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
K821974
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 39d
Cleared Aug 02, 1977
CHOLEDOCHOSCOPE SYSTEM
K771367
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 8d