# K061638: Best Strand and Best Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Best Medical International, Inc.
- Decided: Aug 4, 2006 after 53 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: 4 generations back to K010621 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034062: CP Sleeve and River Sleeve, Cp Medical (2004) Summary page 1.
- K940632: I-125 Rapid Strand, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1994) Summary page 1.
- K010821: Echoseed/Iodine-125 Seeds, Model 6733, Medi-Physics Inc. Dba Nycomed Amersham Imaging (2001) Summary page 1.

## Indications for use
The Best Medical International, Inc Best Strand component device is indicated for use as an accessory in brachytherapy procedures. It is supplied sterile, as a single-use device. The Best Strand is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures. The Best Medical International, Inc., "Best Spacer" device is intended to be used to maintain a predetermined space between radionuclide seeds during the introduction of the seeds into the body during Brachytherapy procedures. Absorbable spacers are indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K061638
Methodology: https://510kreport.com/methodology