510(k) Report

Devices descending from K201399

8 later devices reach HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+2K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+2K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+3K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+3K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+3K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+4K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+4K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—