Data / Medical devices / United States / Anuncia Medical, Inc.
Anuncia Medical, Inc.: FDA-registered device maker in Scottsdale, AZ, United States, 2 510(k) clearances
Anuncia Medical, Inc. is registered with the FDA (registration 3014522419) in Scottsdale, AZ, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014522419
- Address
- 6908 E Thomas Rd Ste 302, Scottsdale, AZ, United States, 85251
- Owner or operator
- Anuncia Medical (10057485)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 25, 2022
- Registered through
- 2026
- Brand names listed
- ReFlow System Mini, ReFlow System Mini and ReFlow Mini Flusher
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Shunt, Central Nervous System And Components | JXG | 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 |
|---|---|---|---|---|---|---|
| December 29, 2022 | K223603 | Reflow System Mini and ReFlow Mini Flusher | JXG | Substantially Equivalent | Anuncia Medical, Inc. | accessdata.fda.gov |
| September 29, 2022 | K221918 | ReFlow System Mini | JXG | Substantially Equivalent | Anuncia Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 29, 2022. 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.