510(k) Report

Devices descending from K984358

30 later devices reach Olympus Distal Attachment, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243388Disposable Distal CapMicro-Tech (Nanjing) Co., Ltd.20251—
+1K250296Disposable Distal Attachment D-201 SeriesOlympus Medical Systems Corp.20251—
+1K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeSumitomo Bakelite Co., Ltd.20180—
+1K171673Focus CapGce Medical Corporation20180—
+1K122565Arc EndocuffBoddingtons Plastics, Ltd.20124—
+1K070330Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.200713—
+1K050578Cook Ireland Duette Multi-Band Mucosectomy DeviceCook Ireland, Ltd.20054—
+2K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation20260—
+2K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.20260—
+2K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd.20160—
+2K160846AmplifEYEMedivators, Inc.20160—
+2K140595Third Eye Panoramic Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20142—
+2K140726Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device for…Boston Scientific Corp20142—
+2K133359EndoringsEndo-Aid, Inc.20141—
+2K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+2K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc.20110—
+2K083180Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20095—
+3K190512SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareIntelligent Endoscopy20191—
+3K190030Embrella Endoscopic Distal AttachmentMicro-Tech (Nanjing) Co., Ltd.20190—
+3K180911Visura Technologies TEECAD SystemVisura Technologies, LLC20180—
+3K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+3K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+3K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.20160—
+3K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+3K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+3K091783Third Eye Retroscope Auxiliary Endoscope SystemAvantis Medical Systems, Inc.20094—
+4K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P…STERIS Corporation20210—
+4K190669EndoticsEra Endoscopy S.R.L.20200—
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+4K093187Modification to Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc.20093—