510(k) Report

Devices descending from K100275

15 later devices reach Working Element, Resection Button Electrode for Plasma Vaporizaton… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152092Resection ElectrodesOlympus Winter & Ibe GmbH201551
+1K122716Plasmatrode Saline Safe Tur ElectrodeCook Ireland, Ltd.20130—
+1K120418Electrosugrical Resection and Vaporization Electrode SeriesOlympus Winter & Ibe GmbH201222
+1K102781Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Olympus Winter & Ibe GmbH201151
+2K221522HF-cables (resusable)Olympus Winter & Ibe GmbH20230—
+2K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH201731
+2K161600Resection ElectrodesOlympus Winter & Ibe GmbH20160—
+2K153055ACE Electrosurgical Resection and Vaporization Electrodes SeriesAce Medical Devices Pvt., Ltd.20160—
+2K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc.20123—
+3K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH202111
+3K210394Electrosurgical accessoryDornier Medtech America, Inc.20210—
+3K163090Plasma Edge SystemChirurgie Innovation20172—
+4K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.20230—
+4K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation20221—
+5K240504PLASMA EDGE SystemLamidey Noury Medical20240—