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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 2 other decisions in the tracker over the last 12 months: K254090 (I-View®), K262792 (Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)).

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