Home / 510(k) Clearances / K220656

510(k) K220656

iovera System by Pacira Biosciences, Inc. — Product Code GXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2022
Date Received
March 7, 2022
Clearance Type
Special
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 Pacira Biosciences, Inc.

  • K243677 — iovera° System (December 26, 2024)

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)
  • 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)
  • K161835 — iovera system (March 24, 2017)