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510(k) K243157

AtriCure cryoICE BOX (ACM) by AtriCure, Inc. — Product Code GXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2024
Date Received
September 30, 2024
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 AtriCure, Inc.

  • K252056 — Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (July 24, 2025)
  • K250371 — cryoICE cryoXT cryoablation probe (cryoXT) (April 10, 2025)
  • K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM) (January 15, 2025)
  • K234151 — Isolator Synergy EnCapture Ablation System (EMH) (August 27, 2024)
  • K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM) (July 29, 2024)
  • K233959 — EPi-Ease Epicardial Access Device (EAS) (February 13, 2024)
  • K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); Atri (November 2, 2023)
  • K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablatio (October 26, 2023)
  • K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® L (December 30, 2022)
  • K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (July 26, 2021)

Other clearances for product code GXH

  • K250371 — cryoICE cryoXT cryoablation probe (cryoXT) (April 10, 2025)
  • K243677 — iovera° System (December 26, 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)
  • K161835 — iovera system (March 24, 2017)