510(k) Report

Devices descending from K103375

20 later devices reach Plumepen Integrated Smoke Evacuation Pencil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230547PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation…Conmed Corporation20231—
+1K213317ShinEvac Smoke Evacuation PencilShining World Health Care Co., Ltd.20221—
+1K200372Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencilModern Medical Equipment Manufacturing, Ltd.20201—
+1K182772Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation…Covidien20184—
+1K120454Safeair Smoke Pencil,Lna Medical Aps20128—
+2K260466Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional…Zhejiang shuyou Surgical Instrument Co., Ltd.20260—
+2K250400Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Vigeon Technology Co., Ltd.20250—
+2K240572Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10)…Covidien, LLC20240—
+2K220996DuobladeCnc Technologies20231—
+2K210315Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch…Modern Medical Equipment Manufacturing, Ltd.20220—
+2K202962Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button…New Deantronics Taiwan, Ltd.20200—
+2K143103PROPENCIL Smoke PencilBio Protech, Inc.20150—
+2K143145SafeAir Smoke PencilLina Medical Aps201448
+2K142538LiNA SafeAir Smoke PencilLina Medical Aps20145—
+2K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+3K252211Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T…Cnc Technologies20250—
+3K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation20163—
+4K160693Neptune E-SEP Smoke Evacuation PencilStryker Corporation20162—
+5K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button…Stryker Instruments20260—
+5K182354SafeAir Telescopic Smoke PencilLina Medical Aps201804