510(k) Report

Devices descending from K053436

22 later devices reach Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+1K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.2009161
+1K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+1K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc.20061—
+2K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+2K142441cryoICE croablation probeAtriCure, Inc.20141—
+2K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+2K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+3K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+3K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+3K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+3K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+3K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+3K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+3K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+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—
+4K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+4K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+5K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+5K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—