510(k) K140964 ยท GEX Powered Laser Surgical Instrument
CALCULASE II
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Sep 4, 2014 |
| Received | Apr 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140964
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.