Gyrus Acmi, Inc.

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K252487	POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)	GEI	2026-03-02	View
510(k)	K233275	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)	FGB	2024-03-25	View
510(k)	K231327	POWERSEAL Sealer and Divider	GEI	2023-10-25	View
510(k)	K221306	SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories	GEX	2023-01-27	View
510(k)	K212650	Celeris, Disposable Sinus Debrider	ERL	2022-01-19	View
510(k)	K213831	Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle	GEI	2022-01-04	View
510(k)	K211401	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)	GEX	2021-06-03	View
510(k)	K181696	ChitoZolve	LYA	2018-11-30	View
510(k)	K180086	Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter	FGE	2018-03-08	View
510(k)	K170908	PK AIM	GEI	2017-05-19	View
510(k)	K163373	PK AIM	GEI	2016-12-12	View
510(k)	K161038	PK Morcellator	GEI	2016-10-07	View
510(k)	K161825	PK AIM	GEI	2016-09-26	View
510(k)	K152744	DIEGO ELITE DRILL	ERL	2016-06-10	View
510(k)	K152531	InstaClear Lens Cleaner	EOB	2016-01-15	View
510(k)	K123429	OLYMPUS ENERGY POWER SYSTEM (EPS)	GEI	2013-04-05	View
510(k)	K122605	PKS BILL	HIN	2012-12-05	View
510(k)	K121678	DTAD	ERL	2012-08-30	View
510(k)	K120474	GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY	KCT	2012-07-10	View
510(k)	K120567	GYRUS AMCI PK BUTTON ELECTRODE	FAS	2012-06-20	View