Data / Medical devices / Canada / RP Medical Inc.
RP Medical Inc.: FDA-registered device maker in Kelowna British Columbia, Canada, 1 510(k) clearance
RP Medical Inc. is registered with the FDA (registration 3020767943) in Kelowna British Columbia, Canada. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 25, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020767943
- Address
- 360 Long Ridge Drive, Kelowna British Columbia, Canada, V1V 2R9
- Owner or operator
- RP Medical Inc. (10083048)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 21, 2021
- Registered through
- 2027
- Brand names listed
- Pivot Implant Extraction Osteotome System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Osteotome, Manual | GFI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | Exporter to the US, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 25, 2019 | K181845 | Pivot System Sterilization case | KCT | Substantially Equivalent | Rp Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Table And Attachments, Operating-Room
- All makers of Osteotome, Manual
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Updated November 25, 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.