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 Micro-Tech (Nanjing) Co., Ltd..

1
Total
1
Cleared
240d
Avg days
2023
Since

List of Choledochoscope And Accessories, Flexible/rigid devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Feb 16, 2023
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
K221784
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 240d

How to use this database

This page lists all FDA 510(k) submissions for Choledochoscope And Accessories, Flexible/rigid devices (product code FBN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →