# K082159: Civastring PD-103

- Pathway: 510(k) (Traditional)
- Applicant: Civatech Oncology, Inc.
- Decided: Sep 30, 2008 after 61 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K874787 (1987). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001070: Radiomed Source, Radiomed Corp. (2000)
- K040766: Optisource, Model 1032P, International Brachytherapy S.A. (2004) Summary page 1.
- K023179: Readi-Strand, Model Psstrand, Worldwide Medical Technologies, LLC (2003) Summary page 1.

## Most influential descendants
- K140490: Civa Sheet PD-103 (2014), 0 descendants of its own

## Indications for use
CivaStringPdl° 3 is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized tumors. The device may be used either as the primary treatment or for treatment of residual disease after excision of the primary tumor. CivaStringPdl° 3 may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.

Source page: https://510kreport.com/device/K082159
Methodology: https://510kreport.com/methodology