Gyrus Acmi, Inc. - FDA 510(k) Cleared Devices
42
Total
42
Cleared
0
Denied
42 devices
Cleared
Jun 20, 2012
GYRUS AMCI PK BUTTON ELECTRODE
Gastroenterology & Urology
114d
Cleared
Sep 01, 2011
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
Obstetrics & Gynecology
136d
Cleared
Jul 19, 2011
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
Obstetrics & Gynecology
113d
Cleared
May 20, 2011
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
General Hospital
226d
Cleared
Oct 20, 2010
GYRUS ACMI BIOCOAG PROBE
Gastroenterology & Urology
425d
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
Feb 24, 2010
GYRUS ACMI PK BUTTON ELECTRODE
Gastroenterology & Urology
139d
Cleared
Dec 11, 2009
GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
General Hospital
101d
Cleared
Sep 29, 2009
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
Obstetrics & Gynecology
63d
Cleared
Aug 13, 2009
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
General & Plastic Surgery
505d
Cleared
Apr 20, 2009
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
Gastroenterology & Urology
26d
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
Cleared
May 02, 2008
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
Obstetrics & Gynecology
109d
Cleared
Dec 13, 2007
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
Gastroenterology & Urology
90d