510(k) Report

Devices descending from K965054

9 later devices reach Pencil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240868Ultravision2™ IonPencilAlesi Surgical Limited20240—
+1K192542Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch…Modern Medical Equipment Manufacturing, Ltd.20205—
+1K081647Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode TipsXodus Medical, Inc.20081—
+2K240932HybridTherm SystemErbe Elektromedizin GmbH20241—
+2K231405Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use…Jiangsu Rong FU Kang Medical Instruments Co., Ltd.20240—
+2K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc.20230—
+2K213786CiRX Single use electrosurgical pencil with non-coated and coated electrodeNingbo Shun YE Medical Company, Ltd.20221—
+3K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH20250—
+3K232460Disposable electrosurgical pencil (MD1000)Shenzhen Mecun Medical Supply Co., Ltd.20230—