510(k) Report

Devices descending from K936304

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103375Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc.201120—
+1K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc.200714—
+1K041868Valupen,ProfileConmed Corporation200419—
+2K230547PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation…Conmed Corporation20231—
+2K213317ShinEvac Smoke Evacuation PencilShining World Health Care Co., Ltd.20221—
+2K200372Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencilModern Medical Equipment Manufacturing, Ltd.20201—
+2K182772Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation…Covidien20184—
+2K120454Safeair Smoke Pencil,Lna Medical Aps20128—
+2K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+2K083608Erbe Hybrid KnifeErbe USA, Inc.200913—
+3K260466Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional…Zhejiang shuyou Surgical Instrument Co., Ltd.20260—
+3K250400Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Vigeon Technology Co., Ltd.20250—
+3K240572Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10)…Covidien, LLC20240—
+3K232033HYBRIDknife® flexErbe Elektromedizin GmbH20230—
+3K220996DuobladeCnc Technologies20231—
+3K210315Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch…Modern Medical Equipment Manufacturing, Ltd.20220—
+3K200404ORISE ProKnifeBoston Scientific Corporation20200—
+3K202962Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button…New Deantronics Taiwan, Ltd.20200—
+3K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.201772
+3K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+3K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.201512—
+3K143103PROPENCIL Smoke PencilBio Protech, Inc.20150—
+3K143145SafeAir Smoke PencilLina Medical Aps201448
+3K142538LiNA SafeAir Smoke PencilLina Medical Aps20145—
+3K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+3K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+3K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+4K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…Olympus Medical Systems Corporation20250—
+4K252211Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T…Cnc Technologies20250—
+4K243120HybridAPC probeErbe Elektromedizin GmbH20251—
+4K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH20231—
+4K212999Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd.20220—
+4K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+4K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd.20201—
+4K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare…Hangzhou AGS MedTech Co., Ltd.20200—
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+4K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp.201913
+4K170908PK AIMGyrus Acmi, Inc.20170—
+4K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+4K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+4K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation20163—
+4K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+4K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+5K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+5K253915MOVIVA® Hybrid Ablation ProbeErbe Elektromedizin GmbH20250—
+5K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+5K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+5K211172Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd.20210—
+5K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+5K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+5K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+5K160693Neptune E-SEP Smoke Evacuation PencilStryker Corporation20162—
+6K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button…Stryker Instruments20260—
+6K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+6K182354SafeAir Telescopic Smoke PencilLina Medical Aps201804