Data / Medical devices / United States / Gyrus Acmi, Inc.
Gyrus Acmi, Inc.: FDA-registered device maker in Bartlett, TN, United States, 16 510(k) clearances
Gyrus Acmi, Inc. is registered with the FDA (registration 1037007) in Bartlett, TN, United States. It lists 17 device types. The FDA files 16 510(k) clearances under its listings, the newest dated June 10, 2016. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1037007
- Address
- 2925 Appling Rd, Bartlett, TN, United States, 38133
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 3, 2008
- Registered through
- 2027
- Brand names listed
- 70140095, 70890728, 70890729, 70890730, 70890731, 70890732, 70890733, 70890734 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 10, 2016 | K152744 | DIEGO ELITE DRILL | ERL | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| January 15, 2016 | K152531 | InstaClear Lens Cleaner | EOB | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| April 5, 2013 | K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) | GEI | Substantially Equivalent | Gyrus Acmi, Inc. | accessdata.fda.gov |
| November 8, 2004 | K042516 | OTOMIMIX | NEA | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| March 8, 2002 | K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | ERL | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| June 19, 2000 | K000801 | PC COATED FLUOROPLASTIC VENT TUBES | ETD | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| September 14, 1999 | K983276 | HYDROFERA BACTERISTATIC NASAL DRESSING | EMX | Substantially Equivalent | Hydrofera, LLC | accessdata.fda.gov |
| August 26, 1999 | K992222 | FLUOROPLASTIC VENTILATION TUBES | ETD | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| February 26, 1996 | K960477 | VENTILATION TUBES | ETD | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 10, 1994 | K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) | FST | Substantially Equivalent | Cogent Light Technologies, Inc. | accessdata.fda.gov |
| July 26, 1993 | K932988 | ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY | EOB | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| July 26, 1993 | K932166 | SILICONE TYMPANOSTOMY TUBES | ETD | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| January 20, 1987 | K864402 | BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| March 2, 1982 | K820362 | REUTER BOBBIN VENTILA. TUBE-TITANIUM | ETD | Substantially Equivalent | Richard'S Medical Equip., Inc. | accessdata.fda.gov |
| September 27, 1978 | K781574 | PLASTI-PORE SEPTAL BUTTON | FZE | Substantially Equivalent | Richard'S Medical Equip., Inc. | accessdata.fda.gov |
| September 21, 1976 | K760438 | SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY | ETD | Substantially Equivalent | Richard'S Medical Equip., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 8, 2019 | 82451 | Class II | Terminated | Olympus Diego Elite Console MDCONS 100 | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades | accessdata.fda.gov |
| August 3, 2017 | 79548 | Class II | Ongoing | Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system | "Chattering" when cutting burrs are used in bone. | accessdata.fda.gov |
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Updated June 10, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.