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cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233170

by Atricure, Inc.

Identifiers

510(k) Number
K233170 FDA 510(k)
FDA Product Code
GXH FDA 510(k)
Models / Variants
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) FDA 510(k)
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L) FDA 510(k)
cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX) FDA 510(k)
cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4250 FDA 510(k)
Regulation Number
882.4250 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more models by Atricure, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA 510(k) K233170 24 fields · synced Jun 18, 2026