510(k) Report

Devices descending from K110030

26 later devices reach Expect Endoscopic Aspiration Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133312Expect Slimline Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation20148—
+1K112198Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation201116—
+2K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+2K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation20164—
+2K151738Single Use Aspiration Needle NA-U200HOlympus Medical Systems Corp.20153—
+2K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+2K123676Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies201311—
+3K251542InstaFANOnepass Medical, Ltd.20250—
+3K223616Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation20220—
+3K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+3K181994Single Use Aspiration Needle NA-U201HOlympus Medical Systems Corp.20180—
+3K180449Single Use Aspiration Needle NA-U200HOlympus Medical Systems Corp.20181—
+3K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+3K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—
+3K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd.201712
+3K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+4K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.20250—
+4K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+4K212852Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic…Micro-Tech (Nanjing) Co., Ltd.20210—
+4K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+4K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+4K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+5K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—