FDA.reportPublic FDA data

Fusion Ablation System

Primary DI
00818354012811
Brand
Fusion Ablation System
Company
ATRICURE, INC.
Model
001-700-002
Device description
Fusion 50 Ablation System
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac TissueGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113475000ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEMEndoscopic Technologies, Inc. D/B/A Estech2012-03-20OCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818354012811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818354012811008183540128118183540128110818354012811

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-349-2342xxx@xxx.xxx

Regulatory Flags#

DUNS number
006133784
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10840143913495AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO240A0009662026-04-28
10840143913501AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO245A0009672026-04-28
10840143913518AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO250A000968 2026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150027521Cardioblate™MEDTRONIC, INC.OCL2026-01-16
00199150027538Cardioblate™MEDTRONIC, INC.OCL2026-01-16
00763000841607Cardioblate™ Gemini™-sMEDTRONIC, INC.OCL2025-05-18
10884521851566ValleylabCovidien LPOCL2025-05-12
10840143911767AtriCure Isolator Synergy EnCapture ClampATRICURE, INC.OCL2025-03-14
30840143911761AtriCure Isolator Synergy EnCapture ClampATRICURE, INC.OCL2025-03-14
10884521829527ValleylabCovidien LPOCL2024-10-03
10884521829534ValleylabCovidien LPOCL2024-10-03
00763000841591Cardioblate™ Gemini™-sMEDTRONIC, INC.OCL2024-04-28
10840143905995AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
10840143905834AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
30840143904817AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
10840143905193AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
30840143904114AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
10840143905209AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
10840143905520AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
008105630209538mm CryoprobeVARIAN MEDICAL SYSTEMS, INC.OCL2022-02-18
008105630209608mm CryoprobeVARIAN MEDICAL SYSTEMS, INC.OCL2022-02-18
10840143904134AtriCure Isolator Synergy EnCompass Clamp and GuideSystemATRICURE, INC.OCL2021-08-12
30840143903377AtriCure Isolator Synergy EnCompass Clamp and GuideSystemATRICURE, INC.OCL2021-08-12
10840143904110AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2021-07-29
10840143904127AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2021-07-29
30840143903803Coagulation RF CableATRICURE, INC.OCL2021-05-24
10840143904554EPi-Sense Guided Coagulation System with VisiTraxATRICURE, INC.OCL2021-05-24
10840143904561nContact RF GeneratorATRICURE, INC.OCL2021-05-24
30840143902134nContact RF GeneratorATRICURE, INC.OCL2021-05-24
10840143901454nContact RF GeneratorATRICURE, INC.OCL2021-01-11
10840143902161Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11
10840143902222Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11
10840143902253Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11