Data / Medical devices / United States / Praxis Medical LLC
Praxis Medical LLC: FDA-registered device maker in Tampa, FL, United States, 2 510(k) clearances
Praxis Medical LLC is registered with the FDA (registration 3015980719) in Tampa, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015980719
- Address
- 500 N Willow Ave Ste 101, Tampa, FL, United States, 33606
- Owner or operator
- Praxis Medical LLC (10067293)
- Roles
- Specification developer
- First device listed
- April 4, 2020
- Registered through
- 2026
- Brand names listed
- CytoCore, CytoCore and CytoCore Luer Adapters, EndoCore
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope Accessory | KTI | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 25, 2023 | K230778 | EndoCore | KTI | Substantially Equivalent | Praxis Medical, LLC | accessdata.fda.gov |
| March 31, 2020 | K200278 | CytoCore | KNW | Substantially Equivalent | Praxis Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 25, 2023. 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.