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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 / K261987

510(k) cleared

Reusable SmartPeg

Osstell AB · Sep 8, 2026 · K261987

FDA cleared the Reusable SmartPeg from Osstell AB on Sep 8, 2026 under K261987, a traditional 510(k). The device falls under product code EKX, Handpiece, Direct Drive, Ac-Powered, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on Jun 12, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Osstell AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261987?

K261987 is the FDA 510(k) for Reusable SmartPeg, submitted by Osstell AB. FDA's decision date was Sep 8, 2026, under product code EKX (Handpiece, Direct Drive, Ac-Powered).

Who makes the Reusable SmartPeg?

Osstell AB, based in Goteborg, is the applicant of record for K261987.

How long did the K261987 review take?

FDA received the submission on Jun 12, 2026 and issued its decision on Sep 8, 2026, 88 days later.

← All decisions in September 2026