# K063177: Rapid Strand RX

- Pathway: 510(k) (Traditional)
- Applicant: Oncura, Inc.
- Decided: Nov 30, 2006 after 42 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010621 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030594: I-125 Rapid Strand, Model 7000, Amersham Health (2003) Summary page 1.
- K940632: I-125 Rapid Strand, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1994) Summary page 1.

## Most influential descendants
- K122764: Rapid Strand RX (2012), 0 descendants of its own

## Recalls of this device
- Sep 20, 2011 · Not classified · Z-0266-2012: There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.

## Indications for use
RAPID Strand TM Rx is indicated for permanent interstitial implantation of selected localized tumors, which are low to moderate radio sensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. RAPID StrandTM Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

Source page: https://510kreport.com/device/K063177
Methodology: https://510kreport.com/methodology