Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1037007

FEI Number

1037007

Entity Name

GYRUS ACMI, INC.

City/State/Country

BARTLETT, TN, US

Establishment Address

2925 Appling Rd, BARTLETT, TN 38133, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OLYMPUS CORPORATION (Owner Number: 9067818)

Owner / Operator Contact Address

2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K802873

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2012-09-17
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2008-03-03
FSQ	Light, Surgical, Instrument	General, Plastic Surgery	Class 2	878.4580	2008-03-03
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-02-12
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-03
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2012-09-17
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2012-09-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-04-09
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-03-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-10-22
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-28
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2008-03-03
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2011-11-21
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2008-03-03
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	Class 2	878.3680	2008-03-03
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-06
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-03-06
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-03-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-03
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2010-01-22
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-11
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-03
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-03-03
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
EWA	Set, Audiometer Calibration	Ear, Nose, Throat	Class 1	874.1080	2008-03-03
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2008-03-03
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-11
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-06
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2012-09-17
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2008-03-03
JXX	Forceps, Wire Closure, Ent, Sterile	Ear, Nose, Throat	Class 1	874.3540	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-03-09
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2008-03-03
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2012-09-17
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2016-06-21
GCM	Endoscope, Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-03-03
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2008-03-06
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2008-03-03
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2008-03-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2008-03-03
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2008-03-06
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2008-03-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-03
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-06
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-01-15
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2008-03-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OLYMPUS CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004450998	Gyrus ACMI, Inc.	Redmond, WA, US
3007389669	Algram Group Ltd	Plymouth Devon, GB
9611174	KEYMED (Medical & Industrial Equipment) Ltd	SOUTHEND-ON-SEA Essex, GB
3010590422	QUEST MEDICAL IMAGING	Wieringerwerf Noord-Holland, NL
3031983124	ODIN MEDICAL LIMITED	London London, City of, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

Similar Registrations

Registration Number	Establishment Name	Location
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037007. Last updated year: 2026. Please use registration number 1037007 when referencing this establishment in official correspondence.