510(k) K012556 ยท NML Catheter, Biliary, Reprocessed
REPROCESSED GUIDEWIRES
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Apr 29, 2002 |
| Received | Aug 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc Guidewires - Endoscopic (Jag Wires)
Model #'s:
MIC5658 and
MIC630-100
Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, ri Terminated |
NML | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.