510(k) Report

Devices descending from K854334

23 later devices reach Painblocker WA5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100447Myoscience Cryo-TouchMyoscience, Inc.201010—
+1K050272Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd.200511—
+1K031482Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar…Cryomedical Instruemts, Ltd.200322—
+2K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+2K102021Cryo-Touch IIMyoscience, Inc.20109—
+3K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+3K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+3K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+3K123516Cryo-Touch IVMyoscience, Inc.201371
+3K120415Cryo-Touch IiiMyoscience, Inc.20128—
+4K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+4K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+4K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+4K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+4K133453IoveraMyoscience, Inc.20146—
+5K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+5K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+5K142866Myoscience iovera systemMyoscience, Inc.201551
+6K161835iovera systemMyoscience, Inc.20174—
+7K211334Iovera SystemPacira Pharmaceuticals, Inc.20212—
+7K173763iovera systemMyoscience, Inc.20182—
+8K243677iovera° SystemPacira Biosciences, Inc.20240—
+8K220656iovera SystemPacira Biosciences, Inc.20221—