510(k) Report

Devices descending from K020007

7 later devices reach Safyre Sling System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092233Surgimesh XDAspide Medical20100—
+1K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091—
+1K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081—
+1K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082—
+1K033691Safyre VS and Safyre TPromedon20030—
+1K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.20034—
+2K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090—