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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K254041

510(k) cleared

SkinSmart Antimicrobial HydroGel

Magic Science Supply, LLC · Sep 11, 2026 · K254041

FDA cleared the SkinSmart Antimicrobial HydroGel from Magic Science Supply, LLC on Sep 11, 2026 under K254041, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 16, 2025. The decision came 269 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 Magic Science Supply, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254041?

K254041 is the FDA 510(k) for SkinSmart Antimicrobial HydroGel, submitted by Magic Science Supply, LLC. FDA's decision date was Sep 11, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the SkinSmart Antimicrobial HydroGel?

Magic Science Supply, LLC, based in Edina, MN, is the applicant of record for K254041.

How long did the K254041 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Sep 11, 2026, 269 days later.

← All decisions in September 2026