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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 / K252939

510(k) cleared

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

Cotton High Tech S.L. · Oct 9, 2025 · K252939

FDA cleared the COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS from Cotton High Tech S.L. on Oct 9, 2025 under K252939, a special 510(k). The device falls under product code HEB, Tampon, Menstrual, Unscented, regulated at 21 CFR 884.5470 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Sep 15, 2025. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cotton High Tech S.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252939?

K252939 is the FDA 510(k) for COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS, submitted by Cotton High Tech S.L.. FDA's decision date was Oct 9, 2025, under product code HEB (Tampon, Menstrual, Unscented).

Who makes the COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS?

Cotton High Tech S.L., based in Balsareny, is the applicant of record for K252939.

How long did the K252939 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Oct 9, 2025, 24 days later.

← All decisions in October 2025