BPEndo, LLC FDA Approvals

0 new drug approvals and 2 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
Insufflation Retention Device (IRD) (11173-325-101)510(k)Jul 2, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Jul 2, 2026
Insufflation Retention Device510(k)Jul 21, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 21, 2022