510(k) Report

Devices descending from K152922

6 later devices reach ViziShot FLEX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+2K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+2K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+3K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+3K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+3K230778EndoCorePraxis Medical, LLC20230—