510(k) Report

Devices descending from K944620

125 later devices reach Series 400 Gastroenterology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+5K210915Pathfinder Endoscope CapNeptune Medical, Inc.20210—
+5K203028FUJIFILM Distal End CapFujifilm Corporation20200—
+5K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+5K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation20192—
+5K190030Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd.20190—
+5K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+5K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+5K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+5K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+6K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+6K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+6K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…Fujifilm Corporation20260—
+6K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+6K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+6K242779Hood (DH-083ST)Fujifilm Corporation20240—
+6K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+6K221452DiLumen C1, EZ1 and Tool MountLumendi, LLC20232—
+6K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+6K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2Fujifilm Corporation20210—
+6K190669EndoticsEra Endoscopy S.R.L.20200—
+6K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+7K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+7K231323Ancora-SBAspero Medical, Inc.20231—
+8K260314Ancora-SBAspero Medical, Inc.20260—