Gyrus Acmi, Inc. 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
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)510(k)Mar 2, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 2, 2026
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)510(k)Mar 25, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 25, 2024
POWERSEAL Sealer and Divider510(k)Oct 25, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Oct 25, 2023
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories510(k)Jan 27, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 27, 2023
Celeris, Disposable Sinus Debrider510(k)Jan 19, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jan 19, 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle510(k)Jan 4, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Jan 4, 2022
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)510(k)Jun 3, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Jun 3, 2021