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THE TAPE

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 / June 2026 / K252584

510(k) cleared

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

Weyo Surgical Technology , Ltd. · Jun 25, 2026 · K252584

FDA cleared the Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) from Weyo Surgical Technology , Ltd. on Jun 25, 2026 under K252584, a traditional 510(k). The device falls under product code HIF, Insufflator, Laparoscopic, regulated at 21 CFR 884.1730 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Aug 15, 2025. The decision came 314 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 Weyo Surgical Technology , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252584?

K252584 is the FDA 510(k) for Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C), submitted by Weyo Surgical Technology , Ltd.. FDA's decision date was Jun 25, 2026, under product code HIF (Insufflator, Laparoscopic).

Who makes the Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)?

Weyo Surgical Technology , Ltd., based in Nanjing, is the applicant of record for K252584.

How long did the K252584 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Jun 25, 2026, 314 days later.

← All decisions in June 2026