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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 / K252752

510(k) cleared

ellacor System with Micro-Coring Technology

Cytrellis Biosystems, Inc. · Oct 30, 2025 · K252752

FDA cleared the ellacor System with Micro-Coring Technology from Cytrellis Biosystems, Inc. on Oct 30, 2025 under K252752, a traditional 510(k). The device falls under product code QAI, Powered Microneedle Device, regulated at 21 CFR 878.4430 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 29, 2025. The decision came 62 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cytrellis Biosystems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252752?

K252752 is the FDA 510(k) for ellacor System with Micro-Coring Technology, submitted by Cytrellis Biosystems, Inc.. FDA's decision date was Oct 30, 2025, under product code QAI (Powered Microneedle Device).

Who makes the ellacor System with Micro-Coring Technology?

Cytrellis Biosystems, Inc., based in Woburn, MA, is the applicant of record for K252752.

How long did the K252752 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Oct 30, 2025, 62 days later.

← All decisions in October 2025