AtriCure cryoICE cryoSPHERE cryoablation probe
FDA 510(k) K182565 · AtriCure, Inc.
510(k) numberK182565
Submission
- Device name
- AtriCure cryoICE cryoSPHERE cryoablation probe
- Applicant
- AtriCure, Inc.
Mason, OH, US - Received
- September 18, 2018
- Decision date
- November 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT)GXH · Traditional | AtriCure, Inc. | 04/10/2025SE |
| K243677 | iovera° SystemGXH · Special | Pacira Biosciences, Inc. | 12/26/2024SE |
| K243157 | AtriCure cryoICE BOX (ACM)GXH · Special | AtriCure, Inc. | 10/29/2024SE |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…GXH · Special | AtriCure, Inc. | 10/26/2023SE |
| K220656 | iovera SystemGXH · Special | Pacira Biosciences, Inc. | 05/20/2022SE |
| K211334 | Iovera SystemGXH · Special | Pacira Pharmaceuticals, Inc. | 09/10/2021SE |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…GXH · Traditional | AtriCure, Inc. | 12/23/2020SE |
| K173763 | iovera systemGXH · Traditional | Myoscience, Inc. | 02/28/2018SE |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2)GXH · Special | AtriCure, Inc. | 02/15/2018SE |
| K161835 | iovera systemGXH · Traditional | Myoscience, Inc. | 03/24/2017SE |
More from Myoscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL · Special | 07/24/2025SE |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT)GXH · Traditional | 04/10/2025SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | 01/15/2025SE |
| K243157 | AtriCure cryoICE BOX (ACM)GXH · Special | 10/29/2024SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | 08/27/2024SE |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX · Traditional | 07/29/2024SE |
| K233959 | EPi-Ease Epicardial Access Device (EAS)DYB · Traditional | 02/13/2024SE |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special | 11/02/2023SE |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…GXH · Special | 10/26/2023SE |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | 12/30/2022SE |
Questions and answers
When was AtriCure cryoICE cryoSPHERE cryoablation probe cleared by the FDA?
AtriCure cryoICE cryoSPHERE cryoablation probe (K182565) received a 510(k) decision of Substantially Equivalent on November 9, 2018, 52 days after the submission was received.
What is the product code of K182565?
The FDA product code is GXH – Device, Surgical, Cryogenic, a Class II (moderate risk) device regulated under 21 CFR 882.4250.