Civastring PD-103

FDA 510(k) K082159 · Civatech Oncology, Inc.

Substantially Equivalent

510(k) numberK082159

Submission

Device name
Civastring PD-103
Applicant
Civatech Oncology, Inc.
Mebane, NC, US
Received
July 31, 2008
Decision date
September 30, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

Other 510(k)s with product code KXK

510(k)DeviceApplicantDecision
K252296OncoPatchKXK · Traditional Oncopatch, Inc.12/05/2025SE
K242818IsoSphereKXK · Traditional Isoaid, LLC07/15/2025SE
K223465RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional Radiance Therapeutics, Inc.01/11/2023SE
K221539GammaTileKXK · Traditional Gt Medical Technologies11/09/2022SE
K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional Isoray Medical, Inc.12/31/2020SE
K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special Lv Liberty Vision Corporation05/29/2020SE
K190839GammaTileKXK · Traditional Gt Medical Technologies01/23/2020SE
K191324CivaDermKXK · Traditional Civatech Oncology, Inc.09/20/2019SE
K190296GammaTileKXK · Special Gt Medical Technologies03/13/2019SE
K180515GammaTileKXK · Traditional Isoray Medical, Inc.07/06/2018SE

More from Isoray Medical, Inc.

510(k)DeviceDecision
K191324CivaDermKXK · Traditional 09/20/2019SE
K140490Civa Sheet PD-103KXK · Traditional 08/29/2014SE

Questions and answers

When was Civastring PD-103 cleared by the FDA?

Civastring PD-103 (K082159) received a 510(k) decision of Substantially Equivalent on September 30, 2008, 61 days after the submission was received.

What is the product code of K082159?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.