510(k) Report

Devices descending from K133008

7 later devices reach BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142198BNX Fine Needle Aspiration SystemCovidien, LLC20145—
+1K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20144—
+2K180037Beacon EUS Access SystemCovidien, LLC201802
+2K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.)20153—
+3K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20171—
+3K152586Beacon Fine Needle Fiducial SystemCovidien, LLC20150—
+4K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific20170—