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AtriCure cryoICE cryoSPHERE MAX Cryoablation System

FDA UDI

Class II (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
AtriCure cryoICE cryoSPHERE MAX Cryoablation System FDA UDI
Generic Name
General cryosurgical system, cryogen gas, mechanical FDA UDI
Device Name
Cryoablation Probe FDA UDI
Model / Reference
CRYOSMAX-L FDA UDI
Description
Cryoablation Probe FDA UDI

Identifiers

Catalog Number
A001450 FDA UDI
Primary DI / UDI-DI
10840143911750 FDA UDI
510(k) Number
K233170 FDA UDI
FDA Product Code
GXH FDA UDI
GMDN Term
General cryosurgical system, cryogen gas, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 17 Inch FDA UDI
Outer Diameter — 10 Millimeter FDA UDI

Category: General cryosurgical system, cryogen gas, mechanical

AtriCure cryoICE cryoSPHERE MAX Cryoablation System by Atricure, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General cryosurgical system, cryogen gas, mechanical.

Cleared under the same submission

K233170 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA UDI 2a4e01ae-c72c-4b56-9e47-3748e252716d 38 fields · synced Jun 1, 2026