Data / Medical devices / United States / Npi Solutions Inc.
Npi Solutions Inc.: FDA-registered device maker in Morgan Hill, CA, United States, 1 510(k) clearance
Npi Solutions Inc. is registered with the FDA (registration 3013586954) in Morgan Hill, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013586954
- Address
- 685 Jarvis Drive, Morgan Hill, CA, United States, 95037
- Owner or operator
- NPI Solutions Inc. (10059967)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Reprocessor
- First device listed
- March 15, 2019
- Registered through
- 2026
- Brand names listed
- ONA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer Assisted Hair Harvesting System | ONA | 2 | Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Reprocessor | 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 |
|---|---|---|---|---|---|---|
| March 16, 2018 | K173358 | ARTAS System | ONA | Substantially Equivalent | Restoration Robotics, Inc. | accessdata.fda.gov |
Updated March 16, 2018. 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.