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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 / K262913

510(k) cleared

Protégé EverFlex Self-expanding Peripheral Stent System

Medtronic, Inc. · Sep 17, 2026 · K262913

FDA cleared the Protégé EverFlex Self-expanding Peripheral Stent System from Medtronic, Inc. on Sep 17, 2026 under K262913, a special 510(k). The device falls under product code FGE, Stents, Drains And Dilators For The Biliary Ducts, regulated at 21 CFR 876.5010 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 19, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K262735 (LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)), K262005 (Affera Integrated Mapping System), K261335 (VitalFlow Set with Balance Biosurface), K261866 (Concerto Versa Detachable Coil).

Questions & Answers

What did FDA clear under K262913?

K262913 is the FDA 510(k) for Protégé EverFlex Self-expanding Peripheral Stent System, submitted by Medtronic, Inc.. FDA's decision date was Sep 17, 2026, under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Who makes the Protégé EverFlex Self-expanding Peripheral Stent System?

Medtronic, Inc., based in Plymouth, MN, is the applicant of record for K262913.

How long did the K262913 review take?

FDA received the submission on Aug 19, 2026 and issued its decision on Sep 17, 2026, 29 days later.

← All decisions in September 2026