Gyrus Ent LLC - FDA 510(k) Cleared Devices
Recent clearances: RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM, DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE, HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gyrus Ent LLC General & Plastic Surgery ✕
5 devices
Cleared
Feb 05, 2004
HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
General & Plastic Surgery
129d
Cleared
Aug 26, 2002
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES...
General & Plastic Surgery
88d
Cleared
May 28, 2002
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
General & Plastic Surgery
78d
Cleared
Apr 04, 2002
GYRUS ENT SOMNOPLASTY GENERATOR
General & Plastic Surgery
85d
Cleared
Aug 24, 2000
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
General & Plastic Surgery
52d