# K043117: Best Radiopaque Strand; Best Radiopaque Marker

- Pathway: 510(k) (Traditional)
- Applicant: Best Medical International, Inc.
- Decided: Dec 9, 2004 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K071550: Pre-Waxed Needles with Gold Fiduciary Markers (2007), 4 descendants of its own
- K103449: Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers (2011), 3 descendants of its own
- K131689: Mri Marker (2013), 1 descendant of its own
- K171487: Sirius MRI Marker NS (2017), 0 descendants of its own
- K120859: Pre-Loaded Gold Visicoil CK Marker (2012), 0 descendants of its own

## Indications for use
The Best Radiopaque Strand (Marker Strand) is made of radiopaque xxx a markers (i.e, seeds) and absorbable spacers, inside an absorbable strand, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures. The Best Radiopaque Marker (Marker) is made of a radiopaque xxx solid seed, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K043117
Methodology: https://510kreport.com/methodology