Data / Medical devices / United States / CivaTech Oncology Inc.
CivaTech Oncology Inc.: FDA-registered device maker in Morrisville, NC, United States, 3 510(k) clearances
CivaTech Oncology Inc. is registered with the FDA (registration 3008807866) in Morrisville, NC, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated September 20, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008807866
- Address
- 627 Davis Dr. Tech 7, Suite 200, Morrisville, NC, United States, 27560
- Owner or operator
- Civatech Oncology Inc. (10043507)
- Roles
- Manufacturer
- First device listed
- February 22, 2013
- Registered through
- 2026
- Brand names listed
- CivaDerm, CivaSheet Pd-103, CivaString
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Source, Brachytherapy, Radionuclide | KXK | 2 | 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 |
|---|---|---|---|---|---|---|
| September 20, 2019 | K191324 | CivaDerm | KXK | Substantially Equivalent | Civatech Oncology, Inc. | accessdata.fda.gov |
| August 29, 2014 | K140490 | CIVA SHEET PD-103 | KXK | Substantially Equivalent | Civatech Oncology, Inc. | accessdata.fda.gov |
| September 30, 2008 | K082159 | CIVASTRING PD-103 | KXK | Substantially Equivalent | Civatech Oncology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 20, 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.