FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
FDA 510(k) clearance K183683 · decided 2019-02-27
Clearance details
- K-number
- K183683
- Device name
- FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
- Applicant
- Fujifilm Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-12-28
- Decision date
- 2019-02-27
- Days to decision
- 61 days
- Clearance type
- Special
- Product code
- FDA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ashigara Kami-Gun, JP
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| Ancora-SB (K231323) | Aspero Medical, Inc. | 2023-08-31 |
| Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (K223295) | Fujifilm Corporaton | 2023-01-11 |
| Balloon BS-3 (K213195) | Fujifilm Corporation | 2021-10-29 |
| Arc Enterocuff (K191330) | Boddingtons Plastics, Ltd. | 2020-01-31 |
| FUJIFILM Double Balloon Endoscope EI580BT (K183032) | Fujifilm Corporation | 2019-06-24 |
| Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (K143556) | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-20 |
| SMALL INTESTINAL VIDEOSCOPE SYSTEM (K071254) | Olympus Medical Systems Corporation | 2008-03-25 |
| NAVIAID BGE DEVICE, MODEL 21-001 (K060923) | Smart Medical Systems , Ltd. | 2006-08-15 |
| ENDO-EASE ENDOSCOPIC OVERTUBE (K060235) | Spirus Medical, Inc. | 2006-08-04 |
Recalls involving this device
No recalls on record reference this clearance.