Gyrus Acmi, Inc. - FDA 510(k) Cleared Devices
42
Total
42
Cleared
0
Denied
FDA 510(k) cleared devices by Gyrus Acmi, Inc. General & Plastic Surgery ✕
19 devices
Cleared
Mar 02, 2026
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
General & Plastic Surgery
207d
Cleared
Oct 25, 2023
POWERSEAL Sealer and Divider
General & Plastic Surgery
170d
Cleared
Jan 04, 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
General & Plastic Surgery
27d
Cleared
Jun 03, 2021
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium...
General & Plastic Surgery
28d
Cleared
May 19, 2017
PK AIM
General & Plastic Surgery
52d
Cleared
Dec 12, 2016
PK AIM
General & Plastic Surgery
11d
Cleared
Sep 26, 2016
PK AIM
General & Plastic Surgery
87d
Cleared
Dec 17, 2015
PK AIM
General & Plastic Surgery
132d
Cleared
Jan 13, 2015
PK Cutting Forceps for ESG-400 Workstation
General & Plastic Surgery
110d
Cleared
Jan 08, 2015
PK J-HOOK
General & Plastic Surgery
139d
Cleared
Dec 31, 2014
PK Spatula
General & Plastic Surgery
135d
Cleared
Dec 19, 2014
PK NEEDLE
General & Plastic Surgery
135d
Cleared
Apr 05, 2013
OLYMPUS ENERGY POWER SYSTEM (EPS)
General & Plastic Surgery
149d
Cleared
Jul 01, 2010
PK SUPERPULSE SYSEM GENERATOR MODEL 744000
General & Plastic Surgery
100d
Cleared
Jun 17, 2010
GYRUS ACMI HALO PKS CUTTING FORCEPS
General & Plastic Surgery
78d
Cleared
Aug 13, 2009
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
General & Plastic Surgery
505d
Cleared
Dec 09, 2008
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED...
General & Plastic Surgery
61d
Cleared
Aug 06, 2008
GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL...
General & Plastic Surgery
16d
Cleared
Jul 31, 2008
GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH...
General & Plastic Surgery
22d