Data / Medical devices / United States / Meditrina, Inc.
Meditrina, Inc.: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
Meditrina, Inc. is registered with the FDA (registration 3015512350) in San Jose, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 1, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015512350
- Address
- 1190 Saratoga Ave, Suite 180, San Jose, CA, United States, 95129
- Owner or operator
- Meditrina, Inc. (10061575)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 30, 2019
- Registered through
- 2027
- Brand names listed
- Aveta Auto 5 Fr Disposable Resecting Device, Aveta Auto Disposable Resecting Device, Aveta Cervical Seal, Aveta Controller, Aveta Coral Disposable Hysteroscope, Aveta Disposable Resecting Device, 2.9mm, Aveta Disposable Resecting Device, 3.9mm, Aveta Disposable Resecting Handset and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Insufflator, Hysteroscopic | HIG | 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 |
|---|---|---|---|---|---|---|
| October 1, 2019 | K191958 | Aveta System | HIH | Substantially Equivalent | Meditrina, Inc. | accessdata.fda.gov |
| May 16, 2019 | K190372 | Aveta System | HIH | Substantially Equivalent | Meditrina, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 1, 2019. 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.