510(k) Report

Devices descending from K964577

6 later devices reach Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc.20023—
+1K983206Small Vaginal/Rectal ElectrodeEmpi19980—
+1K972054Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable ElectrodeEmpi19970—
+2K020952Surx RF SystemSurx, Inc.20021—
+2K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc.20022—
+3K042132Novasys Transurethral RF SystemNovasys Medical, Inc.200401