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

K201399 is the FDA 510(k) clearance record for 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, a class II device, cleared for Karl Storz-Endoscopy-America, Inc. on 2020-08-17 under FDA product code OWN (Confocal Optical Imaging). FDA's definition for product code OWN reads: "Collection of light signals for visualization of cellular microstructures". FDA records list 402 510(k) clearances for Karl Storz-Endoscopy-America, Inc., from 1980-04-21 to 2026-05-15. As of 2026-09-10, FDA records show no recalls naming K201399.