510(k) Report

Devices descending from K013255

104 later devices reach Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233604BTL-785SBTL Industries, Inc.20243—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—