FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
FDA 510(k) K251861 · Fujifilm Corporation
510(k) numberK251861
Submission
- Device name
- FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
- Applicant
- Fujifilm Corporation
Ashigara Kami-Gun, JP - Received
- June 17, 2025
- Decision date
- March 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDT – Duodenoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code FDT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315)FDT · Traditional | Olympus Medical Systems Corp. | 02/22/2026SE |
| K251867 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)FDT · Traditional | Olympus Medical Systems Corp. | 09/19/2025SE |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)FDT · Traditional | Olympus Medical Systems Corp. | 06/05/2025SE |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…FDT · Traditional | Pentax of America, Inc. | 08/01/2024SE |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2FDT · Traditional | Ambu A/S | 04/16/2024SE |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDT · Traditional | Olympus Medical Systems Corp. | 05/11/2022SE |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2FDT · Special | Pentax of America, Inc. | 04/09/2021SE |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10FDT · Traditional | Pentax of America, Inc. | 04/01/2021SE |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDT · Traditional | Olympus Medical Systems Corp. | 12/08/2020SE |
| K203028 | FUJIFILM Distal End CapFDT · Special | Fujifilm Corporation | 10/30/2020SE |
More from Fujifilm Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | 09/04/2026SE |
| K261170 | BA-004CCITX · Traditional | 08/12/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | 08/07/2026SE |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET · Special | 07/02/2026SE |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | 06/16/2026SE |
| K254075 | Synapse Lung Nodule AIOEB · Traditional | 05/27/2026SE |
| K254189 | Synapse 3D Base Tools (V7.2)QIH · Traditional | 04/30/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | 04/06/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | 02/17/2026SE |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…FDS · Special | 02/06/2026SE |
Questions and answers
When was FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 cleared by the FDA?
FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 (K251861) received a 510(k) decision of Substantially Equivalent on March 9, 2026, 265 days after the submission was received.
What is the product code of K251861?
The FDA product code is FDT – Duodenoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.