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, Aspero Medical, Inc. and Fujifilm Healthcare Americas Corporation.
20
Total
20
Cleared
142d
Avg days
1981
Since
Declining activity -
2 submissions in the last 2 years
vs 3 in the prior period
Consistent review times:
126d avg (recent)
FDA 510(k) Cleared Enteroscope And Accessories Devices (Product Code FDA)
20 devices
Cleared
May 01, 2026
Ancora-SB
Aspero Medical, Inc.
Gastroenterology & Urology
91d
Cleared
Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology
161d
Cleared
Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology
258d
Cleared
Aug 31, 2023
Ancora-SB
Aspero Medical, Inc.
Gastroenterology & Urology
115d
Cleared
Jan 11, 2023
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
Fujifilm Corporaton
Gastroenterology & Urology
77d
Cleared
Oct 29, 2021
Balloon BS-3
Fujifilm Corporation
Gastroenterology & Urology
30d
Cleared
Jan 31, 2020
Arc Enterocuff
Boddingtons Plastics, Ltd.
Gastroenterology & Urology
260d
Cleared
Jun 24, 2019
FUJIFILM Double Balloon Endoscope EI580BT
Fujifilm Corporation
Gastroenterology & Urology
235d
Cleared
Feb 27, 2019
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
Fujifilm Corporation
Gastroenterology & Urology
61d
About Product Code FDA - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code FDA since 1981, with 20 receiving FDA clearance (average review time: 142 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - FDA Product Code
FDA review times for FDA submissions have been consistent, averaging 126 days recently vs 144 days historically.
FDA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →