Company ยท US
Gyrus Ent LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2004. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 4 |
| ETA | Replacement, Ossicular Prosthesis, Total | 3 |
| ETD | Tube, Tympanostomy | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 |
| EQJ | Bur, Ear, Nose And Throat | 1 |
| ETN | Stimulator, Nerve | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| NIX | Hearing Aid, Air Conduction, Transcutaneous System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2004 | K040996 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM Gyrus Ent LLC | NIX |
| Mar 3, 2004 | K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE Gyrus Ent LLC | ERL |
| Feb 5, 2004 | K033089 | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM Gyrus Ent LLC | GEI |
| Nov 24, 2003 | K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS Gyrus Ent LLC | ETB |
| May 2, 2003 | K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE Gyrus Ent LLC | HAW |
| Oct 24, 2002 | K021595 | GYRUS ENT NERVE STIMULATOR Gyrus Ent LLC | ETN |
| Aug 26, 2002 | K021777 | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) Gyrus Ent LLC | GEI |
| May 28, 2002 | K020778 | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 Gyrus Ent LLC | GEI |
| Apr 4, 2002 | K020067 | GYRUS ENT SOMNOPLASTY GENERATOR Gyrus Ent LLC | GEI |
| Mar 8, 2002 | K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM Gyrus Ent LLC | ERL |
| Oct 31, 2000 | K003214 | SMITH & NEPHEW PISTONS Gyrus Ent LLC | ETB |
| Oct 26, 2000 | K002702 | NEUROTOLOGY DRAPE, MODEL TBD Gyrus Ent LLC | KKX |
| Oct 12, 2000 | K002737 | SMITH & NEPHEW PORPS & TORPS Gyrus Ent LLC | ETB |
| Aug 29, 2000 | K002464 | SMITH & NEPHEW OFF-CENTERED PORP Gyrus Ent LLC | ETB |
| Aug 29, 2000 | K002378 | MODULAR PORP AND TORP MODEL TBD Gyrus Ent LLC | ETA |
| Aug 24, 2000 | K002021 | HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE Gyrus Ent LLC | GEI |
| Jul 10, 2000 | K001902 | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD Gyrus Ent LLC | ETA |
| Jun 19, 2000 | K000801 | PC COATED FLUOROPLASTIC VENT TUBES Gyrus Ent LLC | ETD |
| Apr 3, 2000 | K000858 | WEHRS INCUS-STAPES Gyrus Ent LLC | ETB |
| Feb 11, 2000 | K000256 | CAP PORP, CAP TORP Gyrus Ent LLC | ETB |
| Nov 23, 1999 | K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; Gyrus Ent LLC | ERL |
| Aug 26, 1999 | K992222 | FLUOROPLASTIC VENTILATION TUBES Gyrus Ent LLC | ETD |
| Mar 31, 1999 | K990601 | BOJRAB MICRO-TORP, MODEL 7014-5845 Gyrus Ent LLC | ETA |
| Feb 2, 1999 | K990213 | HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET Gyrus Ent LLC | EOB |
| Mar 4, 1998 | K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT Gyrus Ent LLC | KHJ |
| Jan 12, 1998 | K974232 | ESSENTIAL SHAVER SYSTEM Gyrus Ent LLC | EQJ |
| Sep 29, 1997 | K973286 | ENT IRRIGATING PUMP (70327700) Gyrus Ent LLC | ERL |
| Jan 22, 1997 | K962564 | RICHARDS TOTAL/PARTIAL PROSTHESIS Gyrus Ent LLC | ETB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||