Data / Medical devices / United States / Preceptis Medical, Inc
Preceptis Medical, Inc: FDA-registered device maker in Golden Valley, MN, United States, 2 510(k) clearances
Preceptis Medical, Inc is registered with the FDA (registration 3010610937) in Golden Valley, MN, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 27, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010610937
- Address
- 8401 Wayzata Blvd Suite 110, Golden Valley, MN, United States, 55426
- Owner or operator
- Preceptis Medical Inc. (10045707)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 3, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tube, Tympanostomy | ETD | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 27, 2022 | K221254 | Hummingbird Tympanostomy Tube System | ETD | Substantially Equivalent | Preceptis Medical, Inc. | accessdata.fda.gov |
| August 22, 2014 | K133921 | PRECEPTIS TYMPANOSTOMY TUBE INSERTER | ETD | Substantially Equivalent | Preceptis Medical | accessdata.fda.gov |
Compare with other makers
Updated July 27, 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.