510(k) Report

Devices descending from K000348

15 later devices reach Colorado Microdissection Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082584Given Electrosurgical NeedleTripps Court Enterprises, Inc.20090—
+1K073046Ethicon Endo Surgery Articulating Needle Knife, Model 2504Ethicon Endo-Surgery, Inc.20086—
+1K052297Porex Electrosurgery NeedlePorex Surgical, Inc.20060—
+1K033232Colorado Microdissection NeedleStryker Corp.20045—
+1K012684Reprocessed Electrosurgical ElectrodeSterilmed, Inc.200201
+2K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle…Medline Industries, LP20240—
+2K192128Sutter Arrowtip Monopolar ElectrodesSutter Medizintechnik GmbH20190—
+2K082955Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc.20092—
+2K082114Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00Apollo Endosurgery, Inc.20082—
+2K072124Black and Black Electrosurgical Cutting and Coagulation Forceps and ElectrodesBlack & Black Surgical, Inc.20081—
+3K143662Bissinger Monopolar Forceps and CablesMedagent, Inc.20150—
+3K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc.20110—
+3K093279Navix Access DeviceXlumena201001
+3K091824Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507Ethicon Endo-Surgery, Inc.20090—
+3K091290Ethicon Endo-Surgery Rotating Hook Knife, Model IN2508Ethicon Endo-Surgery, Inc.20090—