FDA — Enteroscope And Accessories Class II
Classification Details
- Product Code
- FDA
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251204 | fujifilm healthcare americas corporation | FUJIFILM Stiffening Wire Device (SW-2000) | September 26, 2025 |
| K233321 | fujifilm healthcare americas corporation | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | June 13, 2024 |
| K231323 | aspero medical | Ancora-SB | August 31, 2023 |
| K223295 | fujifilm corporaton | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | January 11, 2023 |
| K213195 | fujifilm corporation | Balloon BS-3 | October 29, 2021 |
| K191330 | boddingtons plastics | Arc Enterocuff | January 31, 2020 |
| K183032 | fujifilm corporation | FUJIFILM Double Balloon Endoscope EI580BT | June 24, 2019 |
| K183683 | fujifilm corporation | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 | February 27, 2019 |
| K143556 | fujifilm medical systems u.s.a | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | August 20, 2015 |
| K071254 | olympus medical systems corporation | SMALL INTESTINAL VIDEOSCOPE SYSTEM | March 25, 2008 |
| K060923 | smart medical systems | NAVIAID BGE DEVICE, MODEL 21-001 | August 15, 2006 |
| K060235 | spirus medical | ENDO-EASE ENDOSCOPIC OVERTUBE | August 4, 2006 |
| K040048 | fujinon | FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM | June 7, 2004 |
| K031256 | olympus opto-electronics co | XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE | July 23, 2003 |
| K993704 | fujinon | GASTRO-INTESTINAL SYSTEM EN-410WM | February 11, 2000 |
| K904800 | olympus | SIF-SW | March 27, 1991 |
| K840722 | trimedyne | ENTEROSCOPE | June 7, 1984 |
| K841396 | setma | TRANSFER TROLLEY | May 7, 1984 |
| K810757 | american mcgaw | I.V. ADMINISTRATION SET | April 8, 1981 |