Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201399
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 Rubina Camera Head · Karl Storz-Endoscopy-America, Inc. · decided 2020-08-17 (SESE)
FDA 510(k) database ↗Summary PDF ↗
No GUDID device is registered under this submission yet — registration typically lags clearance by months.
Devices
No matching devices.
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