510(k) Report

Devices descending from K131855

13 later devices reach Pentax Video Colonoscopes (EC Family) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…Pentax of America, Inc.20250—
+1K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax of America, Inc.20250—
+1K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…Pentax of America, Inc.20240—
+1K231249PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.202314
+1K210485PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC…Pentax of America, Inc.202102
+1K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope…Pentax of America, Inc.20191—
+1K181084PENTAX Video Colonoscopes (EC Family)Pentax of America, Inc.201932
+1K180285PENTAX Medical Video Colonoscope EC34-i10T SeriesPentax Medical of America, Inc.20180—
+2K251127PENTAX Medical Video Processor (EPK-i8020c)Pentax of America, Inc.202501
+2K232249PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.20230—
+2K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+3K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+4K220158G-EYE SystemSmart Medical Systems, Ltd.20220—