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, 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
1–20 of 20
Cleared May 01, 2026
Ancora-SB
K260314
Aspero Medical, Inc.
Gastroenterology & Urology · 91d
Cleared Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
K251204
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 161d
Cleared Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 258d
Cleared Aug 31, 2023
Ancora-SB
K231323
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
K223295
Fujifilm Corporaton
Gastroenterology & Urology · 77d
Cleared Oct 29, 2021
Balloon BS-3
K213195
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Jan 31, 2020
Arc Enterocuff
K191330
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 260d
Cleared Jun 24, 2019
FUJIFILM Double Balloon Endoscope EI580BT
K183032
Fujifilm Corporation
Gastroenterology & Urology · 235d
Cleared Feb 27, 2019
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
K183683
Fujifilm Corporation
Gastroenterology & Urology · 61d
Cleared Aug 20, 2015
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 248d
Cleared Mar 25, 2008
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K071254
Olympus Medical Systems Corporation
Gastroenterology & Urology · 326d
Cleared Mar 27, 1991
SIF-SW
K904800
Olympus Corp.
Gastroenterology & Urology · 154d
Cleared Jun 07, 1984
ENTEROSCOPE
K840722
Trimedyne, Inc.
Gastroenterology & Urology · 111d

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 →