Panels › Gastroenterology, Urology › Product code FDA · Class 2
Enteroscope And Accessories
Regulation 876.1500
1510(k)s in 12 months (20 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FDA
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujifilm Corporation | 3 | 0 |
| Aspero Medical, Inc. | 2 | 0 |
| FUJIFILM Healthcare Americas Corporation | 2 | 0 |
| Fujinon, Inc. | 2 | 0 |
| American Mcgaw | 1 | 0 |
| Boddingtons Plastics, Ltd. | 1 | 0 |
| Fujifilm Corporaton | 1 | 0 |
| Fujifilm Medical Systems U.S.A, Inc. | 1 | 0 |
| Olympus Corp. | 1 | 0 |
| Olympus Medical Systems Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2026 | K260314 | Ancora-SB Aspero Medical, Inc. | FDA |
| Sep 26, 2025 | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) FUJIFILM Healthcare Americas Corporation | FDA |
| Jun 13, 2024 | K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C FUJIFILM Healthcare Americas Corporation | FDA |
| Aug 31, 2023 | K231323 | Ancora-SB Aspero Medical, Inc. | FDA |
| Jan 11, 2023 | K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D Fujifilm Corporaton, JP | FDA |
| Oct 29, 2021 | K213195 | Balloon BS-3 Fujifilm Corporation, JP | FDA |
| Jan 31, 2020 | K191330 | Arc Enterocuff Boddingtons Plastics, Ltd., GB | FDA |
| Jun 24, 2019 | K183032 | FUJIFILM Double Balloon Endoscope EI580BT Fujifilm Corporation, JP | FDA |
| Feb 27, 2019 | K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 Fujifilm Corporation, JP | FDA |
| Aug 20, 2015 | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T Fujifilm Medical Systems U.S.A, Inc. | FDA |
| Mar 25, 2008 | K071254 | SMALL INTESTINAL VIDEOSCOPE SYSTEM Olympus Medical Systems Corporation | FDA |
| Aug 15, 2006 | K060923 | NAVIAID BGE DEVICE, MODEL 21-001 Smart Medical Systems , Ltd., IL | FDA |
| Aug 4, 2006 | K060235 | ENDO-EASE ENDOSCOPIC OVERTUBE Spirus Medical, Inc. | FDA |
| Jun 7, 2004 | K040048 | FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM Fujinon, Inc. | FDA |
| Jul 23, 2003 | K031256 | XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE Olympus Opto-Electronics Co., Ltd. | FDA |
| Feb 11, 2000 | K993704 | GASTRO-INTESTINAL SYSTEM EN-410WM Fujinon, Inc. | FDA |
| Mar 27, 1991 | K904800 | SIF-SW Olympus Corp. | FDA |
| Jun 7, 1984 | K840722 | ENTEROSCOPE Trimedyne, Inc. | FDA |
| May 7, 1984 | K841396 | TRANSFER TROLLEY Setma, Inc. | FDA |
| Apr 8, 1981 | K810757 | I.V. ADMINISTRATION SET American Mcgaw | FDA |
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