510(k) Report

Devices descending from K042412

12 later devices reach Modified Spacemaker System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151356Spacemaker Pro Access and Dissector SystemCovidien, LLC20150—
+1K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc.20110—
+1K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd.20107—
+1K090631Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie20099—
+2K171939ALVUE Balloon Dilation SystemGlobus Medical, Inc.20180—
+2K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201062
+3K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc.2012415
+3K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.20115—
+4K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc.20152—
+4K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201334
+5K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard20171—
+6K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—