510(k) Report

Devices descending from K962702

11 later devices reach Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973046Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakGeneral Surgical Innovations199810—
+2K171939ALVUE Balloon Dilation SystemGlobus Medical, Inc.20180—
+2K090631Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie20099—
+3K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd.20107—
+4K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201062
+5K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc.2012415
+5K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.20115—
+6K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc.20152—
+6K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201334
+7K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard20171—
+8K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—