Cleared Special

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

K233170 · AtriCure, Inc. · Neurology

Oct 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K233170 is an FDA 510(k) clearance for the cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L), a Device, Surgical, Cryogenic (Class II — Special Controls, product code GXH), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on October 26, 2023, 29 days after receiving the submission on September 27, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4250.

Submission Details

510(k) Number	K233170 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2023
Decision Date	October 26, 2023
Days to Decision	29 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF