FDA · Class II · 21 CFR 876.1500

FDA Product Code FDA: Enteroscope And Accessories

To Provide Visualization And Perform Various Procedures Within The Small Intestine. 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 Fujifilm Corporation.

1
Total
1
Cleared
30d
Avg days
2021
Since

List of Enteroscope And Accessories devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Oct 29, 2021
Balloon BS-3
K213195
Fujifilm Corporation
Gastroenterology & Urology · 30d

How to use this database

This page lists all FDA 510(k) submissions for Enteroscope And Accessories devices (product code FDA). 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 →