510(k) K191747
- Device
- FUJIFILM Duodenoscope Model ED-580XT
- Applicant
- FUJIFILM Corporation
- 510(k) number
- K191747
- Product code
- FDT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-27
- Date received
- 2019-07-01
- Regulation
- 876.1500
- Classification name
- Duodenoscope And Accessories, Flexible/rigid
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Randy Vader
- Address
- 798 Miyanodai Kaisei-Machi Ashigara Kami-Gun JP 258-8538 258-8538
FDA Registration Numbers#
- 3007695959
- 3017210488
- 3004040397
- 9616684
- 1220477
- 3010220595
- 3014605202
- 3010772972
- 9611112
- 3010273872
- 9610691
- 3005099803
- 3002807314
- 9610877
- 3004638277
- 3008386005
- 3042225166
- 1000121056
- 2029011
- 3003637092
- 8010047
- 3011050570
- 3042172882
- 3003782610
- 3010202439
- 9611680
- 2020550
- 3012843412
- 3014055212
- 1225984
- 3006161756
- 3009171251
- 9681260
- 9610595
- 3016497307
- 2032098
Source Documents#
Other 510(k) Records For Product Code FDT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Fujifilm Corporation | 2026-03-09 |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | 2026-02-22 |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025-09-19 |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025-06-05 |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) | Pentax of America, Inc. | 2024-08-01 |
| K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 | Ambu A/S | 2024-04-16 |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2022-05-11 |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | Pentax of America, Inc. | 2021-04-09 |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10 | Pentax of America, Inc. | 2021-04-01 |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-12-08 |
| K203028 | FUJIFILM Distal End Cap | Fujifilm Corporation | 2020-10-30 |
| K201098 | Ambu Duodeno System | Ambu Innovation GmbH | 2020-07-17 |
| K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-01-17 |
| K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation | 2019-12-13 |
| K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | Pentax of America, Inc. | 2019-11-15 |
Legacy Summary#
summary
FDA Review#
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