510(k) K012684 ยท JOS Electrode, Electrosurgical
REPROCESSED ELECTROSURGICAL ELECTRODE
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Jan 18, 2002 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Colorado Electrodes
Model #'s:
COLN104A
COLN112A and
STRN103A
Intended for precision cutting or dissecting and cauterizing soft tissue. Terminated |
JOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.