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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 / K260115

510(k) cleared

DRIM-Nail System

41Medical AG · Sep 11, 2026 · K260115

FDA cleared the DRIM-Nail System from 41Medical AG on Sep 11, 2026 under K260115, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on Jan 14, 2026. The decision came 240 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 41Medical AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260115?

K260115 is the FDA 510(k) for DRIM-Nail System, submitted by 41Medical AG. FDA's decision date was Sep 11, 2026.

Who makes the DRIM-Nail System?

41Medical AG, based in Bettlach, is the applicant of record for K260115.

How long did the K260115 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Sep 11, 2026, 240 days later.

← All decisions in September 2026