FDA.reportPublic FDA data

AtriCure Isolator Synergy EnCapture Clamp

Primary DI
30840143911761
Brand
AtriCure Isolator Synergy EnCapture Clamp
Company
ATRICURE, INC.
Model
EMH
Catalog number
A001433SB
Device description
Isolator Synergy EnCapture Clamp
Published
2025-03-14
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

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
K234151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234151000Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.2024-08-27OCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143911761PackageGS11In Commercial Distribution
50840143911765PackageGS16In Commercial Distribution
10840143911767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084014391176130840143911761
5084014391176550840143911765
1084014391176710840143911767

GMDN Terms#

Term, Definition table
TermDefinition
Epicardial radio-frequency ablation probe, open-surgeryA rigid handpiece and bipolar electrode assembly intended to deliver radio-frequency alternating current, from an appropriate cardiac radio-frequency ablation system generator, to ablate areas of the epicardium of a beating heart in the treatment of cardiac arrhythmias, during an open-surgical procedure. It is available in a variety of designs (e.g., clamp-like probe); it is not designed for endoscopic/minimally-invasive access. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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

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
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
10840143902574Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11