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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 / K261710

510(k) cleared

AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors

Apyx Medical Corporation · Aug 21, 2026 · K261710

FDA cleared the AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors from Apyx Medical Corporation on Aug 21, 2026 under K261710, a traditional 510(k). The device falls under product code QPB, System, Suction, Lipoplasty For Removal, regulated at 21 CFR 878.5040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on May 22, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Apyx Medical Corporation has one other decision in the tracker over the last 12 months: K253396 (AYON Body Contouring System (AYON SYSTEM)).

Questions & Answers

What did FDA clear under K261710?

K261710 is the FDA 510(k) for AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors, submitted by Apyx Medical Corporation. FDA's decision date was Aug 21, 2026, under product code QPB (System, Suction, Lipoplasty For Removal).

Who makes the AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors?

Apyx Medical Corporation, based in Clearwater, FL, is the applicant of record for K261710.

How long did the K261710 review take?

FDA received the submission on May 22, 2026 and issued its decision on Aug 21, 2026, 91 days later.

← All decisions in August 2026

Sources