510(k) Report

Devices descending from K091107

8 later devices reach Model P8400 Hemostatix Thermal Scalpel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233185MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel SystemC2dx, Inc.20230—
+1K183009Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable BladesHemostatix Medical Technologies, LLC20180—
+1K110439Domain Surgical SystemDomain Surgical, Inc.20115—
+2K121881Domain Surgical SystemDomain Surgical, Inc.20124—
+3K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc.20143—
+4K141484Open FmsealerDomain Surgical, Inc.201411
+4K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+5K142229Laparoscopic FMsealerDomain Surgical, Inc.20150—