510(k) K201399 · OWN Confocal Optical Imaging
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubin
| Applicant | Karl Storz-Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Aug 17, 2020 |
| Received | May 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201399
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.