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510(k) K211334

Iovera System by Pacira Pharmaceuticals, Inc. — Product Code GXH

K211334 is an FDA 510(k) premarket notification submitted by Pacira Pharmaceuticals, Inc. for the device "Iovera System". The FDA issued a decision of Substantially Equivalent on September 10, 2021. The device falls under product code GXH (Device, Surgical, Cryogenic), a Class II device regulated under 21 CFR 882.4250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2021
Date Received
May 3, 2021
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 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)
  • 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)

FDA data resources