510(k) Report

Devices descending from K093181

4 later devices reach Gyrus Acmi PK Button Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc.20123—
+2K163090Plasma Edge SystemChirurgie Innovation20172—
+3K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation20221—
+4K240504PLASMA EDGE SystemLamidey Noury Medical20240—