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 / K260203

510(k) cleared

Fule Vertebroplasty Balloon Catheter

Beijing Fule Science & Technology Development Co., Ltd. · Aug 28, 2026 · K260203

FDA cleared the Fule Vertebroplasty Balloon Catheter from Beijing Fule Science & Technology Development Co., Ltd. on Aug 28, 2026 under K260203, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 23, 2026. The decision came 217 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beijing Fule Science & Technology Development Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K253155 (Fule Metallic Lockable Intramedullary Nail Systems), K253151 (Fule Interbody Fusion Cage System), K252730 (Fule Spinal Fixation System).

Questions & Answers

What did FDA clear under K260203?

K260203 is the FDA 510(k) for Fule Vertebroplasty Balloon Catheter, submitted by Beijing Fule Science & Technology Development Co., Ltd.. FDA's decision date was Aug 28, 2026, under product code HRX (Arthroscope).

Who makes the Fule Vertebroplasty Balloon Catheter?

Beijing Fule Science & Technology Development Co., Ltd., based in Beijing, is the applicant of record for K260203.

How long did the K260203 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Aug 28, 2026, 217 days later.

← All decisions in August 2026

Sources