510(k) Report

Devices descending from K192542

5 later devices reach Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240932HybridTherm SystemErbe Elektromedizin GmbH20241—
+1K231405Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use…Jiangsu Rong FU Kang Medical Instruments Co., Ltd.20240—
+1K213786CiRX Single use electrosurgical pencil with non-coated and coated electrodeNingbo Shun YE Medical Company, Ltd.20221—
+2K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH20250—
+2K232460Disposable electrosurgical pencil (MD1000)Shenzhen Mecun Medical Supply Co., Ltd.20230—