Iterative Scopes, 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
SKOUT® system510(k)Jul 3, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Jul 3, 2024
SKOUT® system510(k)Apr 19, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Apr 19, 2024
SKOUT® system510(k)Apr 7, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Apr 7, 2023
SKOUT Software510(k)Aug 12, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Aug 12, 2022