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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 / June 2026 / K253634

510(k) cleared

CoolSeal Generator® (CSL-200-90)

Hologic, Inc. · Jun 17, 2026 · K253634

FDA cleared the CoolSeal Generator® (CSL-200-90) from Hologic, Inc. on Jun 17, 2026 under K253634, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 19, 2025. The decision came 210 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hologic, Inc. has 3 other decisions in the tracker over the last 12 months: K262792 (Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)), K251868 (Panther Fusion GI Bacterial Assay), K251993 (Panther Fusion GI Expanded Bacterial Assay).

Questions & Answers

What did FDA clear under K253634?

K253634 is the FDA 510(k) for CoolSeal Generator® (CSL-200-90), submitted by Hologic, Inc.. FDA's decision date was Jun 17, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the CoolSeal Generator® (CSL-200-90)?

Hologic, Inc., based in Malborough, MA, is the applicant of record for K253634.

How long did the K253634 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Jun 17, 2026, 210 days later.

← All decisions in June 2026

Sources