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 / K261447

510(k) cleared

CVAC® Aspiration System

Calyxo, Inc. · Sep 15, 2026 · K261447

FDA cleared the CVAC® Aspiration System from Calyxo, Inc. on Sep 15, 2026 under K261447, a traditional 510(k). The device falls under product code FGB, Ureteroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 1, 2026. The decision came 137 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Calyxo, Inc. has 2 other decisions in the tracker over the last 12 months: K260965 (CVAC Aspiration System), K260013 (CVAC Image Processor).

Questions & Answers

What did FDA clear under K261447?

K261447 is the FDA 510(k) for CVAC® Aspiration System, submitted by Calyxo, Inc.. FDA's decision date was Sep 15, 2026, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the CVAC® Aspiration System?

Calyxo, Inc., based in Pleasanton, CA, is the applicant of record for K261447.

How long did the K261447 review take?

FDA received the submission on May 1, 2026 and issued its decision on Sep 15, 2026, 137 days later.

← All decisions in September 2026

Sources