# K111979: Radioactive Seed Localization Needle

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles, Inc.
- Decided: Oct 18, 2011 after 98 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122704: Best Localization Needle with I-125 Seed (2013), 1 descendant of its own
- K141701: I-125 RSLN [Radioactive Seed and Localization Needle] (2014), 0 descendants of its own
- K142668: Lesion-Loc Iodine I-125 Seed/Needle (2014), 0 descendants of its own

## Indications for use
The BrachySciences Radioactive Seed Localization Needle with AnchorSeed is intended for the localization of suspicious tissues (non-palpable lesions) for excision with the use of radioactive seeds

Source page: https://510kreport.com/device/K111979
Methodology: https://510kreport.com/methodology