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..