BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GYRUS ACMI, INC.

    Reg #: 1037007 · FEI: 1037007 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    239
    Establishment Types
    3
    Classifications
    33

    Registration Details

    Registration Name
    GYRUS ACMI, INC.
    Registration Number
    1037007
    FEI Number
    1037007
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2925 Appling Rd
    City
    BARTLETT
    State
    TN
    ZIP
    38133
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020067

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Prosthesis, Partial Ossicular Replacement ETB
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
    Light, Surgical, Instrument FSQ
    Light, Surgical, Fiberoptic FST
    Replacement, Ossicular Prosthesis, Total ETA
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Bur, Ear, Nose And Throat EQJ
    Balloon, Epistaxis EMX
    Ear Wick KCN
    Prosthesis, Nose, Internal FZE
    Stimulator, Nerve ETN
    Neurological Stereotaxic Instrument HAW
    Set, Audiometer Calibration EWA
    Tubing, Noninvasive GAZ
    Tube, Tympanostomy ETD
    Gauze / Sponge,Nonresorbable For External Use NAB
    Forceps, Wire Closure, Ent, Sterile JXX
    Applicator, Ent KCJ
    Splint, Nasal EPP
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Endoscope, Rigid GCM
    Staple, Implantable GDW
    Splint, Intranasal Septal LYA
    Mold, Middle-Ear ETC
    Instrument, Ent Manual Surgical LRC
    Speculum, Ent EPY
    Bone Grafting Material, Synthetic LYC
    Tube, Ear Suction JZF
    System, Vocal Cord Medialization MIX
    Cement, Ear, Nose And Throat NEA
    Prosthesis, Ear, Internal FZD
    Cannula, Sinus KAM

    Proprietary Names

    Cogent 1 Dornhoffer Ti PORP Vocom Vocal Cord Medial Shim Vocom Vocal Cord Mdlz Micro Bright Diego Spine Zimmer Diego Spine Richards Pistons Piston Teflon/Wire Mangham Pistons Mass Eye and Ear Pistons Dela Cruz Pistons Micron II CTR TORP Monolithic All Titanium Micron II OCTR All Titanium TORP Micron II CTR PORP Monlithic All Titanium Adj. Micron Ti TORP Micron II OCTR PORP Monolithic All Titanium Powered Suction Pump Diego Elite PK Diego Blades Diego Powered Dissectors Diego PK Console Bipolar Nasal cautery Woodes Incudo Stapeidial joint Vokovic I-S Joint replacement plastipore Applebaum Incudo-stapedial Needle Sleeve Bending Tool Irrigating Blade Diamond Burrs Diego Blades Viper Mastoid Burrs Mastoid Round Cutting Burrs Dermabrader Stapes Cutting Burrs Burr BLU Epistaxis Pack BLU Glide Nasal Pack BLU Nasal Pack Rosette Packing Blu Ear Wick Plasti-Pore Septal Button Silicone Septal Button Wehrs Incus Protheses Wehrs II Incus Stapes Tilt-Top TORP Pros-Pls Sheehy TORP Shea Pls TORP Pros Shea Lg Hd Malleus Sheehy Modified TORP/PORP Pros Diego Trigger Console Diego Powered Dissector Diego Tube Set Diego Otology Tube Set Diego Causse Piston Fluoroplastic Piston Classic Stapes Prosthesis Arrigg II Piston RC-2 Reusable Cable RC-20 Reusable Cable Model 2420 Probe Needle for Nerve Stimulator Stimulator Probe Pod Woods Incus Stapes Goldenberg Incus Stapes Grote Incus Stapes Meyerhoff Incus Kartush Incus Stapes McGee Off Center TORP Goldenberg PORP/TORP Black Oval TORP/PORP Diego Universal Adaptor Diego Starlink Handpiece Schuring Ossicle Columella Centered PORP/TORP Austin Modified TORP Spanner Strut Off-Centered PORP/TORP Dornhoffer Footplates Otoview scope Teleschi Suct Vacuum-powered body fluid suction apparatus Irrigation Bag Spike Assy Black Oval Top Malony Mod PORP/TORP Ultrasil Sheehy-Type Collar Button Armstrong Bevelled Grommet Ultrasil Paparella Paparella Ultrasil Ultasil Richards T Tube Ultrasil Shepared Grommet Shepard Grommet Sheehy Collar Button Collar Button, Pacific Straight Vent Tube Reuter Bobbin, Pacific Armstrong Grommet Berger Bobbin Vent Tube Reut-Bob Vent Tubes Micron Bobbin Vent Tubes Fluoroplastic/Titanium Bobbin Micron Spoon Bobbin Occular Occluder Micro instrument wipe Shah Aural dressing House Wire Closure Forceps Seda Wire Closing Forceps McGee Wire Closing Forceps Otoview Cupped Forceps Return Electrodes Smart Malleous Pistons Smart 360 Pistons Smart Stapes Pistons Smart Dela Cruz Pistons Duberstein applicator Univ Ext Nasal Splint AF Nasal Splint Model 1120 Fergusson Suction Richards Sinuscope Hajek Sphenoid Suction Irrigation Sheath Frontal Ostium Forceps DE Drill High Speed Drill Fiber Optic Light Cable Autoclavable scope Grasping Forceps Shea PORP Goldenberg Cap Shea Cap Shea TORP Williams Microclips Autoclavable Scope Sinuscope Model 1010 Wide Line Nasal Pack 70140095 70890735 Slim Line Nasal Pack 70890732 70890738 70890730 70890737 70890751 70890739 70890743 70890742 70890753 70890740 70890752 70890734 70890728 70890733 70890754 70890731 70890756 70890729 70890750 70890741 70890755 70890757 Sheehy-Type Collar Button Richards T-Tubes Modified T-Tube Silicone Paparella-Type Vent Tubes Paparella 2000 Bivalve Splint Std Spetal Splint Std Neiman Sil RB Nasal Splint Gyrus G3 Generator Trapeze Ribbon Loop Model 2220 Model 1200 InstaClear Ti Bucket Handle Classic Stapes Pros. Tit. Shea Plat Cup Piston Lippy Mod Bucket Handle Titanium Richards Bucket Handle Titanium Richards BH Pros Flpl Porous Hydroxylapatite Attic Defect Viper Drill Diego Viper Turbo 7000 Applebaum Incus Replacement Grote Incus Prothesis Kartush Incus Strut Goldenberg Incus Prosth. RND SOPI OPI Killian Septum Speculum Buck Ear Currette Austin Tympanoplasty Richards Ritter-Halle Frontal Sinus Dilator Chest support Synergry Drill system Barnhill Adenoid Articulated arm and accessories Joseph Skin Hook Cottle Septum Speculum Bellucci Mic Scissors Double Spoon Biopsy Forceps RP Osteotome Delacruz measuring Russell-Davis Tongue Bld OTRP Trial Moriyama Univ. Cutt. Fcps Bojrab Dissector Boucheron Ear Speculum Holmgren Speculum Hartmann Ear Speculum Politzer Ear Speculum Gruber Ear Speculum Speculum and accessories Porous Hydroxlapatite granules Kartush Hydroxlapatite Disks Frazier Suction Tube Baron Suction Tube Ferguson-Frazier Suction tube Verhoven Suction Tube Vocom Otomimix Otologic cement Grote Canal Wall Shepard Grommet Tube Spoon-Bobbin Vent Tubes Jahn Tube Hydroxlapatite Jahn Hydroxlvent Shepard Grommet Vent Tube Spoon-Bobbin Vent Tube Turner Drain Tube Pope Beveled Grommet Reut-Bob Vent Tube Septal Needle Custom McGee Suction Tube Rains Frontal Sinus Stent

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility