FDA.reportPublic FDA data

cryoICE®

Primary DI
10840143912788
Brand
cryoICE®
Company
ATRICURE, INC.
Model
CRYO2
Catalog number
A001560
Device description
10 cm Cryoablation Probe
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXHDevice, Surgical, Cryogenic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXHDevice, Surgical, CryogenicNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180138000
K200697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180138000AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.2018-02-15GXH
K200697000AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc.2020-12-23GXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143912782PackageGS11In Commercial Distribution
50840143912786PackageGS13In Commercial Distribution
10840143912788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014391278230840143912782
5084014391278650840143912786
1084014391278810840143912788

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
866-449-2342SEhlert@atricure.com

Regulatory Flags#

DUNS number
006133784
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840143912795cryoICE®CRYO3A0015612026-09-29
10840143912801cryoICE® cryoFORM™CRYOFA0015622026-09-29
10840143912832Cannula with GuideCSK-6131CSK-6131-32026-05-31
10840143902666cryoICE® SystemA001150A001150-12026-05-27
10840143902673cryoICE® SystemA001150A001150-22026-05-27
10840143902680cryoICE® SystemA001150A001150-32026-05-27
10840143902697cryoICE® SystemA001150A001150-42026-05-27
10840143902703cryoICE® SystemA001150A001150-52026-05-27
10840143902710cryoICE® SystemA001150A001150-62026-05-27
10840143902727cryoICE® SystemA001150A001150-72026-05-27
10840143902734cryoICE® SystemA001150A001150-82026-05-27
30840143904343cryoICE® SystemCMF1A0013592026-05-27
30840143912164AtriCure® cryoICE® BOXACM1A000896-52026-05-27
30840143913703Multifunctional Ablation GeneratorMAGA0013722026-05-27
10840143913761Isolator Synergy™ OSL2A000432-122026-05-12
10840143913440AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO135A0008242026-04-28
10840143913457AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO140A0008252026-04-28
10840143913464AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO145A0008262026-04-28
10840143913471AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO150A0008272026-04-28
10840143913488AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO235A0009652026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816287020255ioveraPacira Pharmaceuticals, Inc.GXH2026-07-27
00816287020323ioveraPacira Pharmaceuticals, Inc.GXH2026-07-27
00818788022295Epimed International, Inc.EPIMED INTERNATIONAL, INCGXH2025-12-05
10840143917004AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-10-01
10840143912863AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-04-25
30840143912867AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-04-25
10840143911729AtriCure cryoICE cryoSPHERE+ Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911736AtriCure cryoICE cryoSPHERE+ Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911743AtriCure cryoICE cryoSPHERE MAX Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911750AtriCure cryoICE cryoSPHERE MAX Cryoablation SystemATRICURE, INC.GXH2024-02-15
00816287020149iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020187iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020217iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020231iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020132iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020170iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020200iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020224iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020248ioveraPacira Pharmaceuticals, Inc.GXH2023-06-13
10840143902307cryoICE Cryoablation SystemATRICURE, INC.GXH2021-01-08
10840143902321AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2021-01-08
10840143902543AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
10840143902550AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902608cryoICE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902646AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2021-01-08
30840143902912AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902929AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
00818354017885AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2020-03-18
00816287020071ioveraPacira Pharmaceuticals, Inc.GXH2020-02-12
00818354016321AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2018-11-15