WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / K262654

510(k) cleared

Dexus Prosthetic System (MSL2, MSR2)

Zhejiang Qiangnao Technology Co.,Ltd · Aug 27, 2026 · K262654

FDA cleared the Dexus Prosthetic System (MSL2, MSR2) from Zhejiang Qiangnao Technology Co.,Ltd on Aug 27, 2026 under K262654, a special 510(k). The device falls under product code GXY, Electrode, Cutaneous, regulated at 21 CFR 882.1320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 30, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zhejiang Qiangnao Technology Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262654?

K262654 is the FDA 510(k) for Dexus Prosthetic System (MSL2, MSR2), submitted by Zhejiang Qiangnao Technology Co.,Ltd. FDA's decision date was Aug 27, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the Dexus Prosthetic System (MSL2, MSR2)?

Zhejiang Qiangnao Technology Co.,Ltd, based in Hangzhou, is the applicant of record for K262654.

How long did the K262654 review take?

FDA received the submission on Jul 30, 2026 and issued its decision on Aug 27, 2026, 28 days later.

← All decisions in August 2026