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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 / December 2025 / K250488

510(k) cleared

Cerynë Intimate Care

Ansella Therapeutics · Dec 12, 2025 · K250488

FDA cleared the Cerynë Intimate Care from Ansella Therapeutics on Dec 12, 2025 under K250488, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Feb 19, 2025. The decision came 296 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ansella Therapeutics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250488?

K250488 is the FDA 510(k) for Cerynë Intimate Care, submitted by Ansella Therapeutics. FDA's decision date was Dec 12, 2025, under product code NUC (Lubricant, Personal).

Who makes the Cerynë Intimate Care?

Ansella Therapeutics, based in Cypress, TX, is the applicant of record for K250488.

How long did the K250488 review take?

FDA received the submission on Feb 19, 2025 and issued its decision on Dec 12, 2025, 296 days later.

← All decisions in December 2025