Gyrus Ent LLC - FDA 510(k) Cleared Devices
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