AtriCure cryoICE cryoSPHERE cryoablation probe— 510(k) K182565

Name: FDA 510(k) clearance K182565
Creator: U.S. Food and Drug Administration
Published: 2018-11-09

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K182565 for AtriCure cryoICE cryoSPHERE cryoablation probe, Substantially Equivalent on 2018-11-09. Applicant: AtriCure, Inc.. Device class: 2.

Clearance details

Applicant: AtriCure, Inc.
Product code: Code GXH
Device class: Class 2
Regulation: 21 CFR 882.4250
Advisory panel: Neurology
Date received: 2018-09-18
Decision date: 2018-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXH

view all

K250371 — cryoICE cryoXT cryoablation probe (cryoXT)2025-04-10
K243677 — iovera° System2024-12-26
K243157 — AtriCure cryoICE BOX (ACM)2024-10-29
K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more2023-10-26
K220656 — iovera System2022-05-20

More clearances from AtriCure, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.