FDA 510(k) Applications Submitted by GYRUS ENT L.L.C.

FDA 510(k) Number Submission Date Device Name Applicant
K000256 01/28/2000 CAP PORP, CAP TORP GYRUS ENT L.L.C.
K990601 02/24/1999 BOJRAB MICRO-TORP, MODEL 7014-5845 GYRUS ENT L.L.C.
K000801 03/13/2000 PC COATED FLUOROPLASTIC VENT TUBES GYRUS ENT L.L.C.
K000858 03/16/2000 WEHRS INCUS-STAPES GYRUS ENT L.L.C.
K001902 06/22/2000 BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD GYRUS ENT L.L.C.
K002021 07/03/2000 HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE GYRUS ENT L.L.C.
K002378 08/04/2000 MODULAR PORP AND TORP MODEL TBD GYRUS ENT L.L.C.
K002464 08/10/2000 SMITH & NEPHEW OFF-CENTERED PORP GYRUS ENT L.L.C.
K002737 09/01/2000 SMITH & NEPHEW PORPS & TORPS GYRUS ENT L.L.C.
K974311 11/17/1997 VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT GYRUS ENT L.L.C.
K034004 12/24/2003 DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE GYRUS ENT L.L.C.
K040996 04/16/2004 RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM GYRUS ENT L.L.C.
K992222 07/01/1999 FLUOROPLASTIC VENTILATION TUBES GYRUS ENT L.L.C.
K973286 09/02/1997 ENT IRRIGATING PUMP (70327700) GYRUS ENT L.L.C.
K974232 11/12/1997 ESSENTIAL SHAVER SYSTEM GYRUS ENT L.L.C.
K021595 05/15/2002 GYRUS ENT NERVE STIMULATOR GYRUS ENT L.L.C.
K002702 08/30/2000 NEUROTOLOGY DRAPE, MODEL TBD GYRUS ENT L.L.C.
K030343 02/03/2003 DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE GYRUS ENT L.L.C.
K020594 02/22/2002 DIEGO POWERED DISSECTOR AND DRILL SYSTEM GYRUS ENT L.L.C.
K033089 09/29/2003 HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM GYRUS ENT L.L.C.
K033554 11/12/2003 SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS GYRUS ENT L.L.C.
K990213 01/22/1999 HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET GYRUS ENT L.L.C.
K992994 09/07/1999 TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; GYRUS ENT L.L.C.
K020778 03/11/2002 GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 GYRUS ENT L.L.C.
K020067 01/09/2002 GYRUS ENT SOMNOPLASTY GENERATOR GYRUS ENT L.L.C.
K021777 05/30/2002 GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) GYRUS ENT L.L.C.
K003214 10/13/2000 SMITH & NEPHEW PISTONS GYRUS ENT L.L.C.
K962564 07/01/1996 RICHARDS TOTAL/PARTIAL PROSTHESIS GYRUS ENT L.L.C.


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