FDA 510(k) Applications Submitted by Chaitrali Kulkarni

FDA 510(k) Number Submission Date Device Name Applicant
K240075 01/10/2024 FUJIFILM Endoscope Model EB-710XT Fujifilm Healthcare Americas Corporation
K240142 01/18/2024 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP Fujifilm Corporation
K250370 02/10/2025 SCENARIA View Phase 5.0 FUJIFILM Corporation
K241429 05/21/2024 ECHELON Synergy MRI System FUJIFILM Healthcare Corporation
K231574 05/31/2023 Scenaria View 4.2 Fujifilm Healthcare Americas Corporation
K231666 06/07/2023 Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) Fujifilm Healthcare Americas Corporation
K231941 06/30/2023 ARIETTA x10 Fujifilm Healthcare Americas Corporation
K232314 08/02/2023 Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) Fujifilm Healthcare Americas Corporation
K242779 09/13/2024 Hood (DH-083ST) Fujifilm Corporation
K233321 09/29/2023 Double Balloon Endoscope EN-840T, Over-tube TS-1214C FUJIFILM Healthcare Americas Corporation
K243091 09/30/2024 Over-tube (TR-1108A) Fujifilm Corporation
K243260 10/15/2024 FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R Fujifilm Corporation
K243261 10/15/2024 FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L Fujifilm Corporation
K233583 11/07/2023 FCT iSTREAM Phase 1 FUJIFILM Healthcare Americas Corporation
K243512 11/12/2024 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP FUJIFILM Corporation
K233687 11/17/2023 ECHELON Synergy V10.0 Fujifilm Healthcare Americas Corporation
K244017 12/27/2024 FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 FUJIFILM Corporation


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