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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 / July 2026 / K261021

510(k) cleared

EasyWhip Family

Winter Innovations, Inc. · Jul 1, 2026 · K261021

FDA cleared the EasyWhip Family from Winter Innovations, Inc. on Jul 1, 2026 under K261021, a traditional 510(k). The device falls under product code GAT, Suture, Nonabsorbable, Synthetic, Polyethylene, regulated at 21 CFR 878.5000 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 27, 2026. The decision came 96 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 Winter Innovations, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261021?

K261021 is the FDA 510(k) for EasyWhip Family, submitted by Winter Innovations, Inc.. FDA's decision date was Jul 1, 2026, under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Who makes the EasyWhip Family?

Winter Innovations, Inc., based in Knoxville, TN, is the applicant of record for K261021.

How long did the K261021 review take?

FDA received the submission on Mar 27, 2026 and issued its decision on Jul 1, 2026, 96 days later.

← All decisions in July 2026