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510(k) K133453

IOVERA by Myoscience, Inc. — Product Code GXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2014
Date Received
November 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Surgical, Cryogenic
Device Class
Class II
Regulation Number
882.4250
Review Panel
NE
Submission Type

Other clearances by Myoscience, Inc.

  • K173763 — iovera system (February 28, 2018)
  • K161835 — iovera system (March 24, 2017)
  • K142866 — Myoscience iovera system (January 21, 2015)
  • K123516 — CRYO-TOUCH IV (January 10, 2013)
  • K120415 — CRYO-TOUCH III (June 22, 2012)
  • K102021 — CRYO-TOUCH II (September 17, 2010)
  • K100447 — MYOSCIENCE CRYO-TOUCH (June 25, 2010)
  • K083493 — MYOSCIENCE CRYO-TOUCH (March 20, 2009)

Other clearances for product code GXH

  • K250371 — cryoICE cryoXT cryoablation probe (cryoXT) (April 10, 2025)
  • K243677 — iovera° System (December 26, 2024)
  • K243157 — AtriCure cryoICE BOX (ACM) (October 29, 2024)
  • K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablatio (October 26, 2023)
  • K220656 — iovera System (May 20, 2022)
  • K211334 — Iovera System (September 10, 2021)
  • K200697 — AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoa (December 23, 2020)
  • K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe (November 9, 2018)
  • K173763 — iovera system (February 28, 2018)
  • K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2) (February 15, 2018)