510(k) K161555 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
KARL STORZ NAV1 Electromagnetic Navigation System
| Applicant | Karl Storz Endoscopy America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Oct 21, 2016 |
| Received | Jun 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161555
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.