510(k) Report

Devices descending from K142909

7 later devices reach Flexible 19G EBUS Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152922ViziShot FLEXSpiration, Inc.20166—
+2K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+3K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+3K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+4K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+4K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+4K230778EndoCorePraxis Medical, LLC20230—