Fujifilm Duodenoscope Model ED-530XT
FDA 510(k) K152257 · Fujifilm Medical Systems U.S.A, Inc.
510(k) numberK152257
Submission
- Device name
- Fujifilm Duodenoscope Model ED-530XT
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
Wayne, NJ, US - Received
- August 10, 2015
- Decision date
- July 21, 2017
- 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
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|---|---|---|---|
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | Fujifilm Corporation | 03/09/2026SE |
| 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 |
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| K171096 | Fujifilm Diathermic Slitter (FlushKnife)KGE · Special | 05/09/2017SE |
| K170858 | FDR Aqro (Dr-Xd 1000)IZL · Traditional | 04/24/2017SE |
| K162287 | Synapse 3D Perfusion AnalysisLLZ · Traditional | 04/06/2017SE |
| K170451 | FDX Console (DR-ID300CL) SoftwareLLZ · Traditional | 03/16/2017SE |
Questions and answers
When was Fujifilm Duodenoscope Model ED-530XT cleared by the FDA?
Fujifilm Duodenoscope Model ED-530XT (K152257) received a 510(k) decision of Substantially Equivalent on July 21, 2017, 711 days after the submission was received.
What is the product code of K152257?
The FDA product code is FDT – Duodenoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.