510(k) 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 by Karl Storz-Endoscopy-America, Inc. — Product Code OWN

K201399 is an FDA 510(k) premarket notification submitted by Karl Storz-Endoscopy-America, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent on August 17, 2020. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Karl Storz-Endoscopy-America, Inc. has at least 1 other 510(k) clearance on record.