510(k) Report

Devices descending from K231216

4 later devices reach Potenza through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254185Potenza PrimeJeisys Medical Incorporated20260—
+1K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+2K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+2K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—