# K140856: Brachysource Seed Implants with Sourcecap Bioabsorbable Caps

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 2, 2014 after 29 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 K043246 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093663: Radionuclide Brachytherapy Source, C.R. Bard, Inc. (2009) Summary page 1.

## Indications for use
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

Source page: https://510kreport.com/device/K140856
Methodology: https://510kreport.com/methodology