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THE TAPE

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 / January 2026 / K253923

510(k) cleared

PuraStat

3-D Matrix Europe SAS · Jan 7, 2026 · K253923

FDA cleared the PuraStat from 3-D Matrix Europe SAS on Jan 7, 2026 under K253923, a special 510(k). The device falls under product code PHN, Protective Coating, Mucoadhesive Application, For The Rectal Mucosa as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 8, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

3-D Matrix Europe SAS has one other decision in the tracker over the last 12 months: K253924 (PuraStat).

Questions & Answers

What did FDA clear under K253923?

K253923 is the FDA 510(k) for PuraStat, submitted by 3-D Matrix Europe SAS. FDA's decision date was Jan 7, 2026, under product code PHN (Protective Coating, Mucoadhesive Application, For The Rectal Mucosa).

Who makes the PuraStat?

3-D Matrix Europe SAS, based in Caluire Et Cuire, is the applicant of record for K253923.

How long did the K253923 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Jan 7, 2026, 30 days later.

← All decisions in January 2026

Sources