CivaTech Oncology Inc.

FDA Device Registration & Listing · Morrisville, NC, US · Registration 3008807866

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008807866
FEI Number
3008807866
Entity Name
CivaTech Oncology Inc.
City/State/Country
Morrisville, NC, US
Establishment Address
627 Davis Dr., Tech 7, Suite 200, Morrisville, NC 27560, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Civatech Oncology Inc. (Owner Number: 10043507)
Owner / Operator Contact Address
627 Davis Dr., Suite 200, Morrisville, NC 27560, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191324
PMA Number
N/A

All Registered Proprietary Names

CivaSheet Pd-103 CivaString CivaDerm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2014-11-05
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2013-02-22
KXK Source, Brachytherapy, Radionuclide Radiology Class 2 892.5730 2019-10-09

Official Correspondent

Suzanne Babcock

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Civatech Oncology Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008807866. Last updated year: 2026. Please use registration number 3008807866 when referencing this establishment in official correspondence.
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