FDT
- Product code
- FDT
- Device name
- Duodenoscope And Accessories, Flexible/Rigid
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 35
FDA classification definition
To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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).
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251861 | 2026-03-09 | Fujifilm Corporation | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endosco | |
| K253646 | 2026-02-22 | Olympus Medical Systems Corp. | Single Use Distal Cover MAJ-2315 (MAJ-2315) | |
| K251867 | 2025-09-19 | Olympus Medical Systems Corp. | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V ( | |
| K250701 | 2025-06-05 | Olympus Medical Systems Corp. | Evis Exera III Duodenovideoscope Olympus TJF-Q190V ( | |
| K233942 | 2024-08-01 | Pentax of America, Inc. | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PEN | |
| K233886 | 2024-04-16 | Ambu A/S | Ambu® aScope Duodeno 2, Ambu® aBox 2 |
Official FDA classification page: FDT
Classification and pathway per current FDA publications. Data from openFDA (CC0).