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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 / K262151

510(k) cleared

SpaceOAR Flex System

Boston Scientific Corporation · Sep 11, 2026 · K262151

FDA cleared the SpaceOAR Flex System from Boston Scientific Corporation on Sep 11, 2026 under K262151, a traditional 510(k). The device falls under product code OVB, Hydrogel Spacer, regulated at 21 CFR 892.5725 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 25, 2026. The decision came 78 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K262460 (Rezum System), K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance System), K262406 (EluPro Antibiotic-Eluting BioEnvelope).

Questions & Answers

What did FDA clear under K262151?

K262151 is the FDA 510(k) for SpaceOAR Flex System, submitted by Boston Scientific Corporation. FDA's decision date was Sep 11, 2026, under product code OVB (Hydrogel Spacer).

Who makes the SpaceOAR Flex System?

Boston Scientific Corporation, based in Marlborough, MA, is the applicant of record for K262151.

How long did the K262151 review take?

FDA received the submission on Jun 25, 2026 and issued its decision on Sep 11, 2026, 78 days later.

← All decisions in September 2026