510(k) Report

Devices descending from K050503

28 later devices reach Single Use Aspiration Needle NA-201SX-4022 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+1K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+1K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+1K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+1K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+1K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+2K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+2K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+2K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+2K152922ViziShot FLEXSpiration, Inc.20166—
+2K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+3K250145Biopsy Port AdapterEndosound, Inc.20250—
+3K231267ClearTipFinemedix Co., Ltd.20231—
+3K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+3K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+3K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+3K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+3K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+4K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+4K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+4K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+4K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+4K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+4K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+4K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+5K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+5K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+5K230778EndoCorePraxis Medical, LLC20230—