510(k) K012679 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
REPROCESSED RF ARTHROSCOPY PROBES
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 8, 2001 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc RF Arthroscopy Probe
Model #'s:
ARTA1325-01
ARTA1335-01
ARTA1345-01
ARTA1730-01
ARTA2630-01
ARTA3625-01
ARTA4330-01
ARTAS1335-01
ARTAS4630-01
ARTASC1335-01
ARTASC2530-01
ARTASC4250-01
ARTASC4830-01 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.