510(k) K201135 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Image1 S CCU, Image1 S 4U Camera Head
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Sep 1, 2020 |
| Received | Apr 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201135
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.