Enteroscope And Accessories
FDA product code FDA · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
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).
20510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Fujifilm Corporation 3
- Fujinon, Inc. 2
- Aspero Medical, Inc. 2
- FUJIFILM Healthcare Americas Corporation 2
- American Mcgaw 1
- Setma, Inc. 1
- Trimedyne, Inc. 1
- Olympus Corp. 1
- Olympus Opto-Electronics Co., Ltd. 1
- Spirus Medical, Inc. 1
- Smart Medical Systems , Ltd. 1
- Olympus Medical Systems Corp. 1
- Fujifilm Medical Systems U.S.A, Inc. 1
- Boddingtons Plastics, Ltd. 1
- Fujifilm Corporaton 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260314 | Ancora-SBFDA · Traditional | Aspero Medical, Inc. | 05/01/2026SE |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000)FDA · Traditional | FUJIFILM Healthcare Americas Corporation | 09/26/2025SE |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214CFDA · Traditional | FUJIFILM Healthcare Americas Corporation | 06/13/2024SE |
| K231323 | Ancora-SBFDA · Traditional | Aspero Medical, Inc. | 08/31/2023SE |
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFDA · Special | Fujifilm Corporaton | 01/11/2023SE |
| K213195 | Balloon BS-3FDA · Special | Fujifilm Corporation | 10/29/2021SE |
| K191330 | Arc EnterocuffFDA · Traditional | Boddingtons Plastics, Ltd. | 01/31/2020SE |
| K183032 | FUJIFILM Double Balloon Endoscope EI580BTFDA · Traditional | Fujifilm Corporation | 06/24/2019SE |
| K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5FDA · Special | Fujifilm Corporation | 02/27/2019SE |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFDA · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 08/20/2015SE |
| K071254 | Small Intestinal Videoscope SystemFDA · Traditional | Olympus Medical Systems Corporation | 03/25/2008SE |
| K060923 | Naviaid Bge Device, Model 21-001FDA · Traditional | Smart Medical Systems , Ltd. | 08/15/2006SE |
| K060235 | Endo-Ease Endoscopic OvertubeFDA · Traditional | Spirus Medical, Inc. | 08/04/2006SE |
| K040048 | Fujinon Double Balloon Enteroscopy SystemFDA · Traditional | Fujinon, Inc. | 06/07/2004SE |
| K031256 | XSIF-1TQ140A Small Intestinal VideoscopeFDA · Traditional | Olympus Opto-Electronics Co., Ltd. | 07/23/2003SE |
| K993704 | Gastro-Intestinal System EN-410WMFDA · Traditional | Fujinon, Inc. | 02/11/2000SE |
| K904800 | Sif-SwFDA · Traditional | Olympus Corp. | 03/27/1991SE |
| K840722 | EnteroscopeFDA · Traditional | Trimedyne, Inc. | 06/07/1984SE |
| K841396 | Transfer TrolleyFDA · Traditional | Setma, Inc. | 05/07/1984SE |
| K810757 | I.V. Administration SetFDA · Traditional | American Mcgaw | 04/08/1981SE |