510(k) K012685 ยท NLW Electrode, Electrosurgical, Active, Urological, Reprocessed
REPROCESSED ENDOSCOPIC ELECTRODES
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Feb 14, 2002 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012685
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc TURP Electrodes
Model #'s:
CIRMLE-24-012
CIRMLE-24-015
OLYA22205C
STO27050F
STO27050G and
STO27050NK
Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation Terminated |
NLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.