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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 / October 2025 / K253040

510(k) cleared

Aevumed FASE Suture Anchor

Aevumed, Inc. · Oct 21, 2025 · K253040

FDA cleared the Aevumed FASE Suture Anchor from Aevumed, Inc. on Oct 21, 2025 under K253040, a special 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 22, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Aevumed, Inc. has 2 other decisions in the tracker over the last 12 months: K254306 (Aevumed FENIX Suture Anchor), K260004 (Aevumed PROTEKT Suture Anchor).

Questions & Answers

What did FDA clear under K253040?

K253040 is the FDA 510(k) for Aevumed FASE Suture Anchor, submitted by Aevumed, Inc.. FDA's decision date was Oct 21, 2025, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Aevumed FASE Suture Anchor?

Aevumed, Inc., based in Malvern, PA, is the applicant of record for K253040.

How long did the K253040 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Oct 21, 2025, 29 days later.

← All decisions in October 2025

Sources