Device, Surgical, Cryogenic
Neurology · 21 CFR 882.4250
Recent MDR events
52 adverse event reports on file
- ATRICURE CRYOICE CRYOSPHERE+ CRYOABLATION SYSTEMApr 3, 2026MalfunctionAtricure, Inc.24775711
- IOVERA - RIGHT KNEE CRYONEUROLYSISFeb 25, 2026InjuryPacira Pharmaceuticals, Inc.MW5184403
- CRYOICE CRYOSPHERE MAX CRYOABLATION PROBEDec 23, 2025InjuryAtricure, Inc.3011706110-2025-00045
- CRYOICE CRYOSPHERE MAX CRYOABLATION PROBEDec 22, 2025InjuryAtricure, Inc.3011706110-2025-00043
- ATRICURE CRYOICE CRYOSPHERE+ CRYOABLATION SYSTEMOct 29, 2025MalfunctionAtricure, Inc.23412815
- CRYOSPHERE MAX11Aug 25, 2025MalfunctionAtricure, Inc.MW5175189
- ATRICURE CRYOICE BOX (ACM)May 28, 2025InjuryAtricure, Inc.3011706110-2025-00024
- CRYOICE CRYOSPHERE CRYOABLATION PROBEAug 6, 2024InjuryAtricure, Inc.3011706110-2024-00049
- CRYOICE CRYOSPHERE CRYOABLATION PROBEJan 4, 2024InjuryAtricure, Inc.3011706110-2024-00001
- ATRICURE CRYOICE CRYOABLATION SYSTEM (CRYO2)Jun 16, 2023MalfunctionAtricure, Inc.17142629
Event type breakdown
Recalls
2 recall events for this product code
- Myoscience IncTerminatedJul 22, 2015
iovera 155 Smart Tip;
The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
Z-2201-2015 · View FDA record ↗ - Myoscience IncTerminatedJul 20, 2013
Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10.
The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
Z-1781-2013 · View FDA record ↗
Registered firms
28 firms currently registered for this product code
Eurofins Infinity Laboratory Group Inc.
San Jose, CA, US
Isomedix Operations Inc
GROVEPORT, OH, US
Isomedix Operations, Inc.
Libertyville, IL, US
Integra Biotechnical, Sa De Cv
Tijuana Baja California, MX
Isomedix Operations, Inc.
Libertyville, IL, US
Pacira Pharmaceuticals, Inc
San Diego, CA, US
Atricure, Inc.
Mason, OH, US
Epimed International, Inc.
JOHNSTOWN, NY, US
Sterigenics Us Llc
Los Angeles, CA, US
Epimed International, Inc.
Dallas, TX, US
510(k) clearances
23 clearances for this product code
- AtriCure, Inc.Apr 10, 2025
K250371 · cryoICE cryoXT cryoablation probe (cryoXT)
- Pacira Biosciences, Inc.Dec 26, 2024
K243677 · iovera° System
- AtriCure, Inc.Oct 29, 2024
K243157 · AtriCure cryoICE BOX (ACM)
- AtriCure, Inc.Oct 26, 2023
K233170 · cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
- Pacira Biosciences, Inc.May 20, 2022
K220656 · iovera System
- Pacira Pharmaceuticals, Inc.Sep 10, 2021
K211334 · Iovera System
- AtriCure, Inc.Dec 23, 2020
K200697 · AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
- AtriCure, Inc.Nov 9, 2018
K182565 · AtriCure cryoICE cryoSPHERE cryoablation probe