510(k) K063177 ยท KXK Source, Brachytherapy, Radionuclide
RAPID STRAND RX
| Applicant | Oncura, Inc., North Brunswick NJ, US |
| Decision | Substantially Equivalent, Nov 30, 2006 |
| Received | Oct 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2011 | Medi-Physics Inc. dba GE Healthcare Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration withi Terminated |
KXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.