Calyxo, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
CVAC® Aspiration System510(k)Sep 15, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 15, 2026
CVAC Aspiration System510(k)Apr 13, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Apr 13, 2026
CVAC Image Processor510(k)Mar 6, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 6, 2026
CVAC Aspiration System + CVAC Image Processor510(k)Feb 2, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 2, 2024