510(k) K011657 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
| Applicant | Mick Radio-Nuclear Instruments, Inc., Mt. Vernon NY, US |
| Decision | Substantially Equivalent, Aug 27, 2001 |
| Received | May 29, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011657
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2013 | Varian Medical Systems, Inc. Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. Terminated |
JAQ | None listed |
| Jan 31, 2013 | Varian Medical Systems, Inc. Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. Terminated |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.