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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K253568

510(k) cleared

Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR

Fujifilm Corporation · Feb 6, 2026 · K253568

FDA cleared the Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR from Fujifilm Corporation on Feb 6, 2026 under K253568, a special 510(k). The device falls under product code FDS, Gastroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Nov 17, 2025. The decision came 81 days later, inside the 90 FDA-day goal for a 510(k).

Fujifilm Corporation has 8 other decisions in the tracker over the last 12 months: K261170 (BA-004CC), K260567 (EW10-EC02 Endoscopy Support Program), K261880 (FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01), K253137 (FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T).

Questions & Answers

What did FDA clear under K253568?

K253568 is the FDA 510(k) for Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR, submitted by Fujifilm Corporation. FDA's decision date was Feb 6, 2026, under product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Who makes the Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K253568.

How long did the K253568 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Feb 6, 2026, 81 days later.

← All decisions in February 2026