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 Shenzhen HugeMed Medical Technical Development Co., Ltd., Mirco-Tech (Nanjing) Co., Ltd. and Micro-Tech (Nanjing) Co., Ltd..
FDA 510(k) Cleared Choledochoscope And Accessories, Flexible/rigid Devices (Product Code FBN)
About Product Code FBN - Regulatory Context
510(k) Submission Activity
43 total 510(k) submissions under product code FBN since 1977, with 43 receiving FDA clearance (average review time: 146 days).
Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.
FDA Review Time
Recent submissions under FBN have taken an average of 175 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.
FBN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →