BA-004CC
FDA 510(k) K261170 · Fujifilm Corporation
510(k) numberK261170
Submission
- Device name
- BA-004CC
- Applicant
- Fujifilm Corporation
Ashigara Kami-Gun, JP - Received
- April 9, 2026
- Decision date
- August 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
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| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| 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 |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | 03/09/2026SE |
| 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 BA-004CC cleared by the FDA?
BA-004CC (K261170) received a 510(k) decision of Substantially Equivalent on August 12, 2026, 125 days after the submission was received.
What is the product code of K261170?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.