510(k) Report

Devices descending from K103668

8 later devices reach BNX Fine Needle Aspiration System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133008BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…Beacon Endoscopic20137—
+2K142198BNX Fine Needle Aspiration SystemCovidien, LLC20145—
+2K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20144—
+3K180037Beacon EUS Access SystemCovidien, LLC201802
+3K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20153—
+4K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+4K152586Beacon Fine Needle Fiducial SystemCovidien, LLC20150—
+5K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—