Surmodics,Inc. FDA Approvals

0 new drug approvals and 8 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
Pounce(TM) Sheath510(k)Sep 24, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Sep 24, 2025
Pounce XL Thrombectomy System (PTS-1011-7F135)510(k)Sep 11, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 11, 2024
Microcatheter510(k)Sep 29, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Sep 29, 2023
Pounce Sheath510(k)Sep 7, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 7, 2023
Pounce Thrombectomy System510(k)Jun 12, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 12, 2023
Sublime Microcatheter510(k)Oct 14, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 14, 2022
Pounce Thrombectomy System510(k)Mar 23, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Mar 23, 2022
Pounce Thrombectomy System510(k)Jul 30, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 30, 2021