Data / Medical devices / United States / Stratus Medical
Stratus Medical: FDA-registered device maker in Magnolia, TX, United States, 3 510(k) clearances
Stratus Medical is registered with the FDA (registration 3017423051) in Magnolia, TX, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 7, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017423051
- Address
- 32303 FM 2978 Rd, Magnolia, TX, United States, 77354
- Owner or operator
- Stratus Medical (10077915)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 5, 2020
- Registered through
- 2027
- Brand names listed
- MINTA RYAN RF THERMOCOUPLE ELECTRODE, Nimbus RF Multi-tined Expandable Electrode, Vesta RF Cannula
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Probe, Radiofrequency Lesion | GXI | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 7, 2020 | K190259 | Vesta RF Cannula | GXI | Substantially Equivalent | Biomerics | accessdata.fda.gov |
| September 21, 2012 | K121773 | NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE | GXI | Substantially Equivalent | Biomerics | accessdata.fda.gov |
| June 14, 2010 | K090608 | MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) | GXI | Substantially Equivalent | Minta Medical Limited | accessdata.fda.gov |
Compare with other makers
Updated February 7, 2020. 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.