FDT — Duodenoscope And Accessories, Flexible/Rigid Class II
Classification Details
- Product Code
- FDT
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251861 | fujifilm corporation | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM | March 9, 2026 |
| K253646 | olympus medical systems | Single Use Distal Cover MAJ-2315 (MAJ-2315) | February 22, 2026 |
| K251867 | olympus medical systems | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | September 19, 2025 |
| K250701 | olympus medical systems | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | June 5, 2025 |
| K233942 | pentax of america | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor | August 1, 2024 |
| K233886 | ambu | Ambu® aScope Duodeno 2, Ambu® aBox 2 | April 16, 2024 |
| K220587 | olympus medical systems | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | May 11, 2022 |
| K210710 | pentax of america | PENTAX Medical Video Duedenoscope ED34-i10T2 | April 9, 2021 |
| K202365 | pentax of america | Pentax Medical Video Duodenoscope ED32-i10 | April 1, 2021 |
| K202661 | olympus medical systems | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | December 8, 2020 |
| K203028 | fujifilm corporation | FUJIFILM Distal End Cap | October 30, 2020 |
| K201098 | ambu innovation | Ambu Duodeno System | July 17, 2020 |
| K193182 | olympus medical systems | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | January 17, 2020 |
| K193202 | boston scientific corporation | EXALT Model D Single-Use Duodenoscope, EXALT Controller | December 13, 2019 |
| K192245 | pentax of america | Pentax Medical Video Duodenoscope ED34-i10T2 | November 15, 2019 |
| K192280 | pentax medical | PENTAX Medical ED-3490TK Video Duodenoscope | October 21, 2019 |
| K191747 | fujifilm corporation | FUJIFILM Duodenoscope Model ED-580XT | September 27, 2019 |
| K181745 | fujifilm corporation | FUJIFILM Duodenoscope Model | March 28, 2019 |
| K182051 | fujifilm corporation | FUJIFILM Duodenoscope Model | October 2, 2018 |
| K181522 | pentax of america | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Du | July 9, 2018 |