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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 / August 2026 / K261504

510(k) cleared

PuraStat-RM

3-D Matrix, Inc. · Aug 3, 2026 · K261504

FDA cleared the PuraStat-RM from 3-D Matrix, Inc. on Aug 3, 2026 under K261504, a traditional 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 May 6, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

3-D Matrix, Inc. has one other decision in the tracker over the last 12 months: K261503 (PuraStat GI).

Questions & Answers

What did FDA clear under K261504?

K261504 is the FDA 510(k) for PuraStat-RM, submitted by 3-D Matrix, Inc.. FDA's decision date was Aug 3, 2026, under product code PHN (Protective Coating, Mucoadhesive Application, For The Rectal Mucosa).

Who makes the PuraStat-RM?

3-D Matrix, Inc., based in Newton, MA, is the applicant of record for K261504.

How long did the K261504 review take?

FDA received the submission on May 6, 2026 and issued its decision on Aug 3, 2026, 89 days later.

← All decisions in August 2026