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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K262581

510(k) cleared

GraftGun Universal Graft Delivery System (GDS®)

SurGenTec, LLC · Aug 26, 2026 · K262581

FDA cleared the GraftGun Universal Graft Delivery System (GDS®) from SurGenTec, LLC on Aug 26, 2026 under K262581, a special 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 27, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

SurGenTec, LLC has 6 other decisions in the tracker over the last 12 months: K261381 (TiLink-L SI Joint Fusion System), K262121 (Ion-L Navigated Instruments), K261209 (Ion-L), K260329 (Ion-C Navigation Instruments).

Questions & Answers

What did FDA clear under K262581?

K262581 is the FDA 510(k) for GraftGun Universal Graft Delivery System (GDS®), submitted by SurGenTec, LLC. FDA's decision date was Aug 26, 2026, under product code FMF (Syringe, Piston).

Who makes the GraftGun Universal Graft Delivery System (GDS®)?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K262581.

How long did the K262581 review take?

FDA received the submission on Jul 27, 2026 and issued its decision on Aug 26, 2026, 30 days later.

← All decisions in August 2026

Sources