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Sign in to claim this brandGyrus Acmi, Inc.
United States·US-MF-000034237
Last updated September 17, 2026
What Gyrus Acmi, Inc. makes
The company manufactures partial and total ossicular prostheses for middle ear reconstruction, single-use metal and diamond burs for ear, nose, and throat (ENT) procedures, reusable endoscope sheaths, tympanostomy tubes, polymeric ureteral stents, and electrosurgical systems for surgical applications.
These devices are regulated under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Gyrus Acmi, Inc. manufacture?
Gyrus Acmi, Inc. specializes in surgical and ENT (ear, nose, and throat) devices. Their portfolio includes partial and total ossicular prostheses for middle ear reconstruction, single-use metal and diamond burs for ENT procedures, reusable endoscope sheaths, tympanostomy tubes, polymeric ureteral stents, and electrosurgical systems. These devices are designed for surgical applications in otolaryngology, urology, and general surgery.
Where is Gyrus Acmi, Inc. based, and how does that affect its regulatory oversight?
Gyrus Acmi, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s device classification system (Class I or Class II) and mandatory listing in the FDA’s Unique Device Identifier (UDI) database. This ensures compliance with U.S. medical device requirements and transparency in the regulatory system.
Which regulatory registries or databases list Gyrus Acmi, Inc.’s devices?
Gyrus Acmi, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for identifying medical devices in the U.S., ensuring traceability and compliance with FDA requirements. Listing in the UDI database helps healthcare providers and regulators verify device details, including manufacturer information and classification.
How are Gyrus Acmi, Inc.’s devices classified under FDA regulations?
Gyrus Acmi, Inc.’s devices are classified under FDA’s device classification system as either Class I or Class II. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in FDA’s regulatory framework.
What does the presence of Gyrus Acmi, Inc.’s devices in the FDA UDI database indicate?
The inclusion of Gyrus Acmi, Inc.’s devices in the FDA’s Unique Device Identifier (UDI) database indicates that these devices have been assigned a UDI, a standardized identifier that includes a device identifier and a production identifier. This requirement ensures that each device can be uniquely tracked throughout its lifecycle, improving patient safety, regulatory oversight, and transparency in the healthcare system. The UDI helps healthcare providers and regulators quickly access critical information about the device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 9600, Louisiana Ave. North, , Brooklyn Park, MN, United States
- Website
- olympus-osta.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Dave Joppru
- EUDAMED SRN
- US-MF-000034237
- FDA FEI Number
- 3003790304
- DUNS Number
- —
Catalogue (2823)
Page 6 of 57| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Multi-Flex | 5478220 | FDA UDI | Class II | Unknown |
| Gyrus Acmi, Inc | 140116 | FDA UDI | Class II | Active |
| Gyrus ACMI | 70130925 | FDA UDI | Class I | Active |
| M3 Gold | REXM3-30A | FDA UDI | Class II | Active |
| UroPass | 61254BX | FDA UDI | Class II | Active |
| ShockPulse | SPL-NC | FDA UDI | Class II | Active |
| ShockPulse | SPL-PC | FDA UDI | Class II | Active |
| Soltive | TFL-AVCA | FDA UDI | Class II | Active |
| Gyrus ACMI | REXEIWE-PKFL | FDA UDI | Class II | Active |
| Diego Elite | SB4075RC | FDA UDI | Class I | Active |
| Diego Elite | SB4060RC | FDA UDI | Class I | Active |
| Gyrus ACMI | 714750 | FDA UDI | Class II | Active |
| Gyrus ACMI | 140916 | FDA UDI | Class II | Active |
| Evonos | 70133002 | FDA UDI | Class I | Active |
| Gyrus ACMI | 140897 | FDA UDI | Class II | Active |
| Gyrus Acmi | 130724 | FDA UDI | Class I | Active |
| Gyrus Acmi, Inc | 130064 | FDA UDI | Class I | Active |
| nCare | 1006540 | FDA UDI | Class I | Active |
| Gyrus ACMI | 190A | FDA UDI | Class II | Active |
| Gyrus ACMI | 70130793 | FDA UDI | Class I | Active |
| Gyrus ACMI | 70325701 | FDA UDI | Class II | Unknown |
| Diego Elite | TS101DC | FDA UDI | Class II | Active |
| Gyrus ACMI | 70241380 | FDA UDI | Class II | Active |
| Olympus | TFL-AFS550-NS | FDA UDI | Class II | Active |
| Gyrus Acmi | CB-1265 | FDA UDI | Class I | Active |
| SureGlide | 42BX | FDA UDI | Class I | Active |
| Sof-Curl | SSC8528 | FDA UDI | Class II | Active |
| Tecoflex | 5617026 | FDA UDI | Class II | Active |
| Gyrus Acmi, Inc | 70327043 | FDA UDI | Class I | Active |
| Evonos | 130214 | FDA UDI | Class I | Active |
| Gyrus ACMI | 140856 | FDA UDI | Class II | Active |
| USA Elite | E151 | FDA UDI | Class II | Active |
| Diego Elite | MS4000SS | FDA UDI | Class I | Active |
| Gyrus ACMI | 146044 | FDA UDI | Class II | Active |
| Micron | 70142026 | FDA UDI | Class II | Active |
| Tecoflex | 5614516 | FDA UDI | Class II | Active |
| Diego Elite | MBUR5060DVC | FDA UDI | Class I | Active |
| Soltive | TFL-FBX940R | FDA UDI | Class II | Active |
| Gyrus ACMI | 70140798 | FDA UDI | Class II | Active |
| Gyrus ACMI | 70140990 | FDA UDI | Class II | Active |
| Gyrus ACMI | 890924 | FDA UDI | Class II | Active |
| Gyrus Acmi, Inc | 140337 | FDA UDI | Class II | Active |
| Gyrus ACMI | 140033 | FDA UDI | Class II | Active |
| Soltive | TFL-AFSW | FDA UDI | Class II | Active |
| Gyrus ACMI | 70921893 | FDA UDI | Class II | Active |
| Diego Elite | SB2900SC | FDA UDI | Class I | Active |
| Gyrus ACMI | 70145843 | FDA UDI | Class II | Unknown |
| Olympus | ISM-1200595 | FDA UDI | Class II | Active |
| Gyrus ACMI | 70921379 | FDA UDI | Class II | Unknown |
| Evonos | 130363 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (24)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Gyrus Acmi, Inc. has 24 recall records initiated between February 19, 2007, and March 8, 2019, with statuses recorded as open, classified, or terminated. The reasons cited include potential sterility issues—such as compromised sterility, inadequate sterilization instructions, or failure of packaging to maintain sterility—alongside functional concerns like unintended activation of RF energy features, cutting tool malfunctions (e.g., 'chattering'), and detachment of internal components during use. Additional reports mention particulate matter in catheters and instances of units shipped without sterilization.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 8, 2019 | Z-1183-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1180-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1182-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1184-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1178-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1181-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1187-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1179-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1186-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Z-1185-2019 | — | terminated | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Aug 3, 2017 | Z-1337-2018 | — | open, classified | "Chattering" when cutting burrs are used in bone. |
| Jan 8, 2010 | Z-0797-2010 | — | terminated | Units of the product in lot MH136952 may have been shipped without being sterilized. |
| Aug 18, 2009 | Z-0635-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0632-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0636-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0633-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0637-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Aug 18, 2009 | Z-0634-2010 | — | terminated | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications. Further use of this product should cease, affected product should be removed from stockrooms and returned to Gyrus ACMI. |
| Oct 1, 2008 | Z-0273-2009 | — | terminated | Sterility may be compromised |
| Jun 25, 2008 | Z-2226-2008 | — | terminated | Particulate matter in the catheter |
| May 23, 2007 | Z-1073-2007 | — | terminated | Sterilization Instructions not adequate for sterilizing. |
| Feb 19, 2007 | Z-0613-2007 | — | terminated | Product sterility may be compromised due to failure of the tray seal packaging |
| Feb 19, 2007 | Z-0615-2007 | — | terminated | Product sterility may be compromised due to failure of the tray seal packaging |
| Feb 19, 2007 | Z-0614-2007 | — | terminated | Product sterility may be compromised due to failure of the tray seal packaging |