510(k) Report

Devices descending from K100501

9 later devices reach Multifunctional Linear Pen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130521Isolator Linear PenAtriCure, Inc.20133—
+1K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+2K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+2K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+2K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+3K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+3K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+4K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+4K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—