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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 / September 2025 / K251204

510(k) cleared

FUJIFILM Stiffening Wire Device (SW-2000)

FUJIFILM Healthcare Americas Corporation · Sep 26, 2025 · K251204

FDA cleared the FUJIFILM Stiffening Wire Device (SW-2000) from FUJIFILM Healthcare Americas Corporation on Sep 26, 2025 under K251204, a traditional 510(k). The device falls under product code FDA, Enteroscope And Accessories, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 18, 2025. The decision came 161 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

FUJIFILM Healthcare Americas Corporation has one other decision in the tracker over the last 12 months: K261713 (Synapse PACS (7.6.0)).

Questions & Answers

What did FDA clear under K251204?

K251204 is the FDA 510(k) for FUJIFILM Stiffening Wire Device (SW-2000), submitted by FUJIFILM Healthcare Americas Corporation. FDA's decision date was Sep 26, 2025, under product code FDA (Enteroscope And Accessories).

Who makes the FUJIFILM Stiffening Wire Device (SW-2000)?

FUJIFILM Healthcare Americas Corporation, based in Lexington, MA, is the applicant of record for K251204.

How long did the K251204 review take?

FDA received the submission on Apr 18, 2025 and issued its decision on Sep 26, 2025, 161 days later.

← All decisions in September 2025

Sources