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 Boston Scientific Corporation, KARL STORZ Endoscopy-America, Inc. and Shanghai SeeGen Photoelectric Technology Co., Ltd..

43
Total
43
Cleared
146d
Avg days
1977
Since
43 devices
25–43 of 43
No devices found for this product code.