510(k) Report

Devices descending from K854238

7 later devices reach Needle W/Stylet for Implantation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K942301Microvasive Injection Gold ProbeBoston Scientific Corp19946—
+2K961349Injection Gold ProbeBoston Scientific Corp19965—
+3K110887Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation20114—
+4K133933Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation20143—
+5K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…Boston Scientific20230—
+5K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd.20200—
+5K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.20171—