WHERE ARE YOU?

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

THE TAPE

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 / K254179

510(k) cleared

Drainage Catheter

Canyon Medical, Inc. · Sep 18, 2026 · K254179

FDA cleared the Drainage Catheter from Canyon Medical, Inc. on Sep 18, 2026 under K254179, a traditional 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 Dec 23, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Canyon Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254179?

K254179 is the FDA 510(k) for Drainage Catheter, submitted by Canyon Medical, Inc.. FDA's decision date was Sep 18, 2026, under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Who makes the Drainage Catheter?

Canyon Medical, Inc., based in Nanjing, is the applicant of record for K254179.

How long did the K254179 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Sep 18, 2026, 269 days later.

← All decisions in September 2026