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AtriCure cryoICE Cryoablation System (CRYO2)

FDA UDI

Class II (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
AtriCure cryoICE Cryoablation System (CRYO2) FDA UDI
Generic Name
General cryosurgical system, cryogen gas, mechanical FDA UDI
Device Name
cryoICE 10cm Cryoablation Probe FDA UDI
Model / Reference
CRYO2 FDA UDI
Description
cryoICE 10cm Cryoablation Probe FDA UDI

Identifiers

Catalog Number
A000683-6 FDA UDI
Primary DI / UDI-DI
00818354017885 FDA UDI
510(k) Number
K180138 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 — 10 Centimeter FDA UDI

Category: General cryosurgical system, cryogen gas, mechanical

AtriCure cryoICE Cryoablation System (CRYO2) 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

K180138 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 a3da4849-a4a4-46ef-b892-bfd338c3e28c 37 fields · synced May 30, 2026