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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K261778

510(k) cleared

JADE SCORE PTA Scoring Balloon Dilatation Catheter

OrbusNeich Medical (Shenzhen) Co., Ltd. · Sep 16, 2026 · K261778

FDA cleared the JADE SCORE PTA Scoring Balloon Dilatation Catheter from OrbusNeich Medical (Shenzhen) Co., Ltd. on Sep 16, 2026 under K261778, a traditional 510(k). The device falls under product code PNO, Catheter, Percutaneous, Cutting/Scoring, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 29, 2026. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

OrbusNeich Medical (Shenzhen) Co., Ltd. has one other decision in the tracker over the last 12 months: K253361 (Teleport Glide Microcatheter).

Questions & Answers

What did FDA clear under K261778?

K261778 is the FDA 510(k) for JADE SCORE PTA Scoring Balloon Dilatation Catheter, submitted by OrbusNeich Medical (Shenzhen) Co., Ltd.. FDA's decision date was Sep 16, 2026, under product code PNO (Catheter, Percutaneous, Cutting/Scoring).

Who makes the JADE SCORE PTA Scoring Balloon Dilatation Catheter?

OrbusNeich Medical (Shenzhen) Co., Ltd., based in Shenzhen, is the applicant of record for K261778.

How long did the K261778 review take?

FDA received the submission on May 29, 2026 and issued its decision on Sep 16, 2026, 110 days later.

← All decisions in September 2026

Sources