510(k) Report

Devices descending from K140088

2 later devices reach Phantom XL Insulated Dilators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.20231—
+2K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…Tedan Surgical Innovations20260—