510(k) K111059 ยท HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Sep 1, 2011 |
| Received | Apr 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111059
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.