Data / Medical devices / United States / Medone Surgical, Inc.
Medone Surgical, Inc.: FDA-registered device maker in Sarasota, FL, United States, 1 510(k) clearance
Medone Surgical, Inc. is registered with the FDA (registration 1064371) in Sarasota, FL, United States. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1064371
- FEI number
- 3002865793
- Address
- 670 Tallevast Road, Sarasota, FL, United States, 34243
- Owner or operator
- MEDONE SURGICAL, INC. (9039435)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 27, 1999
- Registered through
- 2026
- Brand names listed
- AcuDepth, AdvantEdge, Auricle, EyeTech, FlexTip, GentleJect, MedOne, MicroDose and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cannula, Trocar, Ophthalmic | NGY | 1 | Manufacturer | accessdata.fda.gov |
| Cystotome | HNY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Scissors, Ear | JZB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| April 26, 2021 | K203264 | MicroDose Injector | FMF | Substantially Equivalent | Medone Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cystotome
- All makers of Scissors, Ophthalmic
- All makers of Forceps, Ophthalmic
- All makers of Spatula, Ophthalmic
- All makers of Cannula, Ophthalmic
- All makers of Syringe, Piston
Updated April 26, 2021. 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.