Creo Medical, Ltd. FDA Approvals

0 new drug approvals and 7 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
SpydrBlade Flex Instrument (PRD-RG1-001)510(k)Jun 6, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 6, 2025
CROMA Electrosurgical Generator (PRD-EMR-050)510(k)Feb 5, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Feb 5, 2025
Reusable Interface Cable 1.5 m (PRD-IFC-002)510(k)Aug 15, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Aug 15, 2024
Speedboat Flush SB1 Instrument510(k)Oct 31, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 31, 2023
AB1 Electrosurgical Instrument, Creo Electrosurgical System510(k)Jun 26, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 26, 2023
Creo Electrosurgical System with NP1 Instrument510(k)Feb 14, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 14, 2023
ABI Instrument, Creo Electrosurgical System510(k)Jan 5, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 5, 2021