BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GYRUS ACMI, INC.

    Reg #: 3003790304 · FEI: 3003790304 · Expires 2026
    View on FDA
    Products
    84
    Proprietary Names
    438
    Establishment Types
    1
    Classifications
    84

    Registration Details

    Registration Name
    GYRUS ACMI, INC.
    Registration Number
    3003790304
    FEI Number
    3003790304
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    800 West Park Drive
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US

    Regulatory Submissions

    510(k) Number
    K830884
    PMA Number
    P180007

    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
    Stent, Ureteral FAD
    Instrument, Ent Manual Surgical LRC
    Dilator, Catheter, Ureteral EZN
    Dilator, Urethral KOE
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Powered Laser Surgical Instrument GEX
    Support, Head, Surgical, Ent EPW
    Endoscopic Irrigation/Suction System OCX
    Replacement, Ossicular Prosthesis, Total ETA
    Dislodger, Stone, Flexible FGO
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Endoscope Channel Accessory ODC
    Tube, Tympanostomy ETD
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Catheter, Nephrostomy LJE
    Forceps, Biopsy, Non-Electric FCL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Lithotriptor, Electro-Hydraulic FFK
    Mold, Middle-Ear ETC
    Prosthesis, Partial Ossicular Replacement ETB
    Splint, Nasal EPP
    Balloon, Epistaxis EMX
    Culdoscope (And Accessories) HEW
    Insufflator, Hysteroscopic HIG
    Valve, Pulmonary NJK
    One-Way Air-Leak Valve OAZ
    System, Abortion, Vacuum HHI
    Curette, Suction, Endometrial (And Accessories) HHK
    Tube, Ear Suction JZF
    Dilator, Esophageal KNQ
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Instrument, Manual, Surgical, General Use MDM
    Applicator, Ent KCJ
    Wire, Guide, Catheter DQX
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Laparoscope, General & Plastic Surgery GCJ
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Prosthesis, Nose, Internal FZE
    Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
    Bronchoscope Accessory KTI
    Biopsy Needle FCG
    Electrode, Electrosurgical, Active, Urological FAS
    Accessories, Catheter, G-U KNY
    Hysteroscope (And Accessories) HIH
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Prosthesis, Ear, Internal FZD
    Lithotriptor, Ultrasonic FEO
    Neurological Stereotaxic Instrument HAW
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Gastroscope And Accessories, Flexible/Rigid FDS
    Set, Audiometer Calibration EWA
    Speculum, Ent EPY
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
    Device, Digital Image Storage, Radiological LMB
    Cystourethroscope FBO
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Unit, Cautery, Thermal, Battery-Powered HQP
    Tray, Surgical, Instrument FSM
    Gauze / Sponge,Nonresorbable For External Use NAB
    Laryngoscope, Rigid CCW
    Ear Wick KCN
    Catheter, Ureteral, Gastro-Urology EYB
    Splint, Intranasal Septal LYA
    Endoscopic Storage Cover OCU
    System, Vocal Cord Medialization MIX
    Laparoscope, Gynecologic (And Accessories) HET
    Bur, Ear, Nose And Throat EQJ
    System, Digital Image Communications, Radiological LMD
    Accessories, Cleaning Brushes, For Endoscope MNL
    Cannula, Sinus KAM
    Resectoscope, Working Element FDC
    Tubing, Noninvasive GAZ
    Stylet, Ureteral EYA
    Stimulator, Nerve ETN
    Endoscopic Cytology Brush FDX
    Electrocautery, Gynecologic (And Accessories) HGI
    Catheter, Suprapubic (And Accessories) KOB
    Evacuator, Gastro-Urology KQT
    Forceps, General & Plastic Surgery GEN
    Staple, Implantable GDW
    Endoscope, Rigid GCM
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Bone Grafting Material, Synthetic LYC

    Proprietary Names

    Uro Guide Perc Antegrade ureteral stent 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 URO EZDilate Grasping forceps Scissors E8218 Biopsy forceps TFL-FBX365R TFL-PLS Powered laser surgical instrument (TFL-AFSWL) TFL-FBX200BS TFL-FBX940R TFL-FBX365S TFL-CPLU TFL-SLS TFL-FBX150R TFL-FBX940S TFL-FBX550R TFL-FBX200S TFL-FBX550S TFL-FBX150BS TFL-FBX200R TFL-CSLU TFL-AFSW TFL-FBX150S Foam head rest IrriFlow McGee Off Center TORP Goldenberg PORP/TORP Black Oval TORP/PORP UltraCatch X-Catch SecurCatch SurLock Flatwire SurLock Grasping Forceps Sur-Catch Baskets SurLock Graspers EAWE-N GW Lock Ultrasil Sheehy-Type Collar Button Armstrong Bevelled Grommet Ultrasil Paparella Paparella Ultrasil Ultasil Richards T Tube Ultrasil Shepared Grommet AUR-735 Biopsy Port Seals Accessory Kit Nephro EZDilate Balloon Catheter FB-225U FB-215U FB-245U FB-210K FB-221K FB-242U FB-230K FB-210U FB-214U FB-235U FB-224U FB-222U FB-41ST-1 FB-211K FB-240K FB-234U FB-244U FB-50U-1 FB-240U FB-231K FB-241K FB-220K FB-230U FLEXIBLE BIOPSY FORCEP FB-212U FB-232U FB-220U FB-26N-1 Model 2220 Model 1200 Extender Cables Electrohydraulic Lithotripsy Probes Porous Hydroxylapatite Attic Defect Cogent 1 Richards Pistons Piston Teflon/Wire Mangham Pistons Mass Eye and Ear Pistons Dela Cruz Pistons Univ Ext Nasal Splint AF Nasal Splint 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 Telescope GY5-PCH IBV Valve System IBV Valve VC-10 Frazier Suction Tube Baron Suction Tube Ferguson-Frazier Suction tube Verhoven Suction Tube Model 1010 Fixed Wire EZDilate 3-Stage Balloon Dilation Catheter MAJ-1453 MAJ-1119 MAJ-422 MAJ-1193 Leakage Tester Adapter Light-guide Adapter Cleaning Accessories Sof-Curl Multi-Flex Double J II Cutting Forceps PKS Cutting Forceps Everest Adapter cord TFL-AFC-NS, TFL-AFS150-NS, TFL-AFS200-NS, TFL-AFS365-NS, TFL-AFS550-NS, TFL-AFS940-NS Tip cleaner Holster Duberstein applicator E-Z Grip Guidewire Torque Device Wehrs Incus Protheses Wehrs II Incus Stapes Jahn Tube Hydroxlapatite Jahn Hydroxlvent Celeris Invisio Black Oval Top Malony Mod PORP/TORP Quadra Coil Stent/GW Combo Diego Spine Zimmer Diego Spine Autoclavable Scope Sinuscope Diego Trigger Console Diego Powered Dissector Diego Tube Set Diego Otology Tube Set Diego Bantam Sm Chuck Handle Assy Endoscopic cord Adapter for Bovie Specialist Unit Plasti-Pore Septal Button Silicone Septal Button Fergusson Suction Richards Sinuscope Hajek Sphenoid Suction Irrigation Sheath Frontal Ostium Forceps Shea PORP Goldenberg Cap Shea Cap Shea TORP PKS BiLL Powered Suction Pump Diego Elite Aspiration needle Hot Knives Vaportrode Loops Cold Knives Uropass Ureteral Access Sheaths Fulgurating Electrode Elite 2 System Reusable Active Cord Roller Electrode Stabilized Cutting Loops McCarthy Electrode Invisio DUR-D InstaClear MR-6A MR-6LA Double J Stent Trapeze Ribbon Loop Grote Canal Wall ShockPulse Diego Universal Adaptor Diego Starlink Handpiece Gyrus G3 Generator Plasma Cise Gyrus Urology Kit Gyrus Plasma V Plasma Cut Cord Gyrus PK Footswitch Shepard Grommet Tube Spoon-Bobbin Vent Tubes Silicone Single J Otoview scope Teleschi Suct DE Drill High Speed Drill Schuring Ossicle Columella Centered PORP/TORP Austin Modified TORP Spanner Strut Off-Centered PORP/TORP Dornhoffer Footplates Boucheron Ear Speculum Holmgren Speculum Hartmann Ear Speculum Politzer Ear Speculum Gruber Ear Speculum Speculum and accessories Lubri-Flex Stents Vocom Vocal Cord Medial Shim Vocom Vocal Cord Mdlz Double Pigtail Footswitch Return Electrodes Tilt-Top TORP Pros-Pls Sheehy TORP Shea Pls TORP Pros Shea Lg Hd Malleus Sheehy Modified TORP/PORP Pros CyberWand Shepard Grommet Sheehy Collar Button Collar Button, Pacific Straight Vent Tube Reuter Bobbin, Pacific Armstrong Grommet EIWE EBC05 EBC02 EBF02 EBF01 Everest Macro Bipolar Forceps Macro Bipolar Forceps Micro Bipolar Forceps Everest Micro Bipolar Forceps WOLF ADAPTER CORD TEL-GT Tray ENDO-ST Tray MRA-GT Tray FGT-1 Tray Woods Incus Stapes Goldenberg Incus Stapes Grote Incus Stapes Meyerhoff Incus Kartush Incus Stapes OPTHALMIC CAUTERY, FINE TIP, STERILE VASECTOMY CAUTERY,ELONGATED TIP HT 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 Endoscopic instrument sterilization trays Various sterilization trays Diego instrument sterilization tray Tray Model 1120 Occular Occluder Micro instrument wipe Shah Aural dressing universal Rosette Packing Blu Ear Wick Dual Lumen Catheter ChitoZolve Shepard Grommet Vent Tube Spoon-Bobbin Vent Tube Turner Drain Tube Pope Beveled Grommet Reut-Bob Vent Tube PK Diego Blades Diego Powered Dissectors Diego PK Console Applebaum Incus Replacement Grote Incus Prothesis Kartush Incus Strut Goldenberg Incus Prosth. Protective Sheath Vocom Plasmasord ASV1012 Varipass Variable Access Sheath ST-CR Irrigating Blade Diamond Burrs Diego Blades Viper Mastoid Burrs Mastoid Round Cutting Burrs Dermabrader Stapes Cutting Burrs Burr G400 Workstation Renal Dilator Ureteral Catheter Causse Piston Fluoroplastic Piston Classic Stapes Prosthesis Arrigg II Piston Model 2420 FTL-DEK-B BW-400V BW-403B MAJ-1339 BW-400B BW-411B BW-412T MAJ-1888 BW-400L Cleaning Accessory FTL-DEK-A Single Use Cleaning Brush Dornhoffer Ti PORP Septal Needle Custom McGee Suction Tube Rains Frontal Sinus Stent Dolphin II Transducer Tubing Dolphin Collection Set 20714 (HYSTEROSCOPE) GYNE-BR Iglesias Vacuum-powered body fluid suction apparatus Irrigation Bag Spike Assy Needle Sleeve Bending Tool RND SOPI OPI UltraTrack Hybrid Guidewire Amplatz E-Z Glider Bentson Probe Needle for Nerve Stimulator Stimulator Probe Pod UroPass II UroPass BC-V600P-3010 CYB-2, CYB-3 Slimline Disposable Bipolar Cord Cyberwand Flex Grasper PK Button adapter Lowsley 188 E8213 GEN. SURGERY FORCEPS Sheehy-Type Collar Button Richards T-Tubes Modified T-Tube Silicone Paparella-Type Vent Tubes Paparella 2000 SlimLine Bivalve Splint Std Spetal Splint Std Neiman Sil RB Nasal Splint Lubri-Flex 568618 Ti Bucket Handle Classic Stapes Pros. Tit. Shea Plat Cup Piston Lippy Mod Bucket Handle Titanium Richards Bucket Handle Titanium Richards BH Pros Flpl Viper Drill Diego Viper Turbo 7000 Berger Bobbin Vent Tube Reut-Bob Vent Tubes Micron Bobbin Vent Tubes Fluoroplastic/Titanium Bobbin Micron Spoon Bobbin PK Cord PK generator SuperLoop SuperPulse generator SuperSect RC-2 Reusable Cable RC-20 Reusable Cable Williams Microclips Smart Malleous Pistons Smart 360 Pistons Smart Stapes Pistons Smart Dela Cruz Pistons Fiber Optic Light Cable Autoclavable scope Grasping Forceps Woodes Incudo Stapeidial joint Vokovic I-S Joint replacement plastipore Applebaum Incudo-stapedial EZDilate SURGICAL CAUTERY, LOOP TIP STERILE SURGICAL CAUTERY, FINE TIP Porous Hydroxlapatite granules Kartush Hydroxlapatite Disks

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility