FDA 510(k) clearance · back to tracker

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

AtriCure, Inc. cleared K200697 on 2020-12-23, decision: substantially equivalent

K-number

K200697

Sponsor

AtriCure, Inc.

Device

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

Class

Class II

Decision

Substantially Equivalent

Decision date

2020-12-23

Product code

GXH

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.4250

Official FDA record

Open K200697on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.