Gyrus Ent LLC
Bartlett, TN, US
Gyrus Ent LLC appears in FDA device records in Bartlett, TN. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Gyrus Ent LLC between 1997 and 2004. The busiest year on record is 2000, with 10. The most recent is 2004, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 10 |
| 2002 | 5 |
| 2003 | 2 |
| 2004 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040996 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | NIX | Substantially Equivalent | |
| K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | ERL | Substantially Equivalent | |
| K033089 | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM | GEI | Substantially Equivalent | |
| K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS | ETB | Substantially Equivalent | |
| K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE | HAW | Substantially Equivalent | |
| K021595 | GYRUS ENT NERVE STIMULATOR | ETN | Substantially Equivalent | |
| K021777 | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | GEI | Substantially Equivalent | |
| K020778 | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 | GEI | Substantially Equivalent | |
| K020067 | GYRUS ENT SOMNOPLASTY GENERATOR | GEI | Substantially Equivalent | |
| K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | ERL | Substantially Equivalent | |
| K003214 | SMITH & NEPHEW PISTONS | ETB | Substantially Equivalent | |
| K002702 | NEUROTOLOGY DRAPE, MODEL TBD | KKX | Substantially Equivalent | |
| K002737 | SMITH & NEPHEW PORPS & TORPS | ETB | Substantially Equivalent | |
| K002464 | SMITH & NEPHEW OFF-CENTERED PORP | ETB | Substantially Equivalent | |
| K002378 | MODULAR PORP AND TORP MODEL TBD | ETA | Substantially Equivalent | |
| K002021 | HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE | GEI | Substantially Equivalent | |
| K001902 | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD | ETA | Substantially Equivalent | |
| K000801 | PC COATED FLUOROPLASTIC VENT TUBES | ETD | Substantially Equivalent | |
| K000858 | WEHRS INCUS-STAPES | ETB | Substantially Equivalent | |
| K000256 | CAP PORP, CAP TORP | ETB | Substantially Equivalent | |
| K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; | ERL | Substantially Equivalent | |
| K992222 | FLUOROPLASTIC VENTILATION TUBES | ETD | Substantially Equivalent | |
| K990601 | BOJRAB MICRO-TORP, MODEL 7014-5845 | ETA | Substantially Equivalent | |
| K990213 | HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET | EOB | Substantially Equivalent | |
| K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT | KHJ | Substantially Equivalent | |
| K974232 | ESSENTIAL SHAVER SYSTEM | EQJ | Substantially Equivalent | |
| K973286 | ENT IRRIGATING PUMP (70327700) | ERL | Substantially Equivalent | |
| K962564 | RICHARDS TOTAL/PARTIAL PROSTHESIS | ETB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EQJBur, Ear, Nose And Throat
- KKXDrape, Surgical, Antimicrobial
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- NIXHearing Aid, Air Conduction, Transcutaneous System
- EOBNasopharyngoscope (Flexible Or Rigid)
- HAWNeurological Stereotaxic Instrument
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- ETBProsthesis, Partial Ossicular Replacement
- ETAReplacement, Ossicular Prosthesis, Total
- ETNStimulator, Nerve
- ETDTube, Tympanostomy
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain