Gyrus Ent LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K040996RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEMAugust 20, 2004
K034004DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLEMarch 3, 2004
K033089HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEMFebruary 5, 2004
K033554SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISNovember 24, 2003
K030343DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACEMay 2, 2003
K021595GYRUS ENT NERVE STIMULATOROctober 24, 2002
K021777GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODAugust 26, 2002
K020778GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420May 28, 2002
K020067GYRUS ENT SOMNOPLASTY GENERATORApril 4, 2002
K020594DIEGO POWERED DISSECTOR AND DRILL SYSTEMMarch 8, 2002
K003214SMITH & NEPHEW PISTONSOctober 31, 2000
K002702NEUROTOLOGY DRAPE, MODEL TBDOctober 26, 2000
K002737SMITH & NEPHEW PORPS & TORPSOctober 12, 2000
K002464SMITH & NEPHEW OFF-CENTERED PORPAugust 29, 2000
K002378MODULAR PORP AND TORP MODEL TBDAugust 29, 2000
K002021HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADEAugust 24, 2000
K001902BOJRAB UNIVERSAL LONG IMLANT, MODEL TBDJuly 10, 2000
K000801PC COATED FLUOROPLASTIC VENT TUBESJune 19, 2000
K000858WEHRS INCUS-STAPESApril 3, 2000
K000256CAP PORP, CAP TORPFebruary 11, 2000