Data / Medical devices / United States / Atricure, Inc.
Atricure, Inc.: FDA-registered device maker in Mason, OH, United States, 51 510(k) clearances and 2 PMA approvals
Atricure, Inc. is registered with the FDA (registration 3011706110) in Mason, OH, United States. It lists 19 device types. The FDA files 51 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 24, 2025. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011706110
- Address
- 7555 Innovation Way, Mason, OH, United States, 45040
- Owner or operator
- ATRICURE, INC. (9045049)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 17, 2004
- Registered through
- 2026
- Brand names listed
- ACC2 AtriCure Cryosurgical Console, ACH2 - AtriClip LAA Exclusion System, ASCB2 - AtriCure System Cart - Basic, ASCF - AtriCure System Cart - Fusion, ASCS - AtriCure System Cart - Simple, Aortic Valve Assistants, AtriClip FLEX-Mini LAA Exclusion System, AtriClip FLEX-V device and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2025 | K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| April 10, 2025 | K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | GXH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| January 15, 2025 | K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | PZX | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| October 29, 2024 | K243157 | AtriCure cryoICE BOX (ACM) | GXH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| August 27, 2024 | K234151 | Isolator Synergy EnCapture Ablation System (EMH) | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| July 29, 2024 | K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | PZX | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| November 2, 2023 | K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | PZX | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| October 26, 2023 | K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | GXH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| December 30, 2022 | K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| May 28, 2021 | K211311 | AtriCure Isolator® Synergy Surgical Ablation System | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| March 3, 2021 | K210293 | AtriClip LAA Exclusion System | PZX | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| December 23, 2020 | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | GXH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| December 13, 2019 | K193162 | EPi-Sense Guided Coagulation System with VisiTrax | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| November 4, 2019 | K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| August 21, 2019 | K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip | PZX | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| July 24, 2019 | K190587 | Coolrail Linear Pen | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| February 25, 2019 | K190151 | COBRA Fusion Ablation System | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| December 4, 2018 | K183065 | Coolrail Linear Pen | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| November 9, 2018 | K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | GXH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| June 28, 2018 | K181474 | ArtiClip LAA Exclusion System | PZX | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| February 15, 2018 | K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | GXH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| February 15, 2018 | K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) | GEH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| January 31, 2018 | K180010 | AtriClip FLEX-V | FZP | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| March 22, 2016 | K152337 | cryoFORM cryoICE cryoablation probe | GEH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| March 18, 2016 | K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | FZP | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| January 27, 2016 | K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip | FZP | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| November 25, 2015 | K153096 | LARIAT RS Suture Delivery Device | GAT | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | GXH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| October 29, 2014 | K142441 | cryoICE croablation probe | GEH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| October 28, 2014 | K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | OCL | Substantially Equivalent | Ncontact Surgical, Inc. | accessdata.fda.gov |
| September 12, 2014 | K142241 | LARIAT sulture Delivery Device | GAT | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| August 28, 2014 | K142120 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP | FZP | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| May 14, 2013 | K131107 | ATRICLIP GILLINOV-COSGROVE LAA CLIP | FZP | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| April 5, 2013 | K130521 | ISOLATOR LINEAR PEN | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| November 13, 2012 | K120857 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | OCL | Substantially Equivalent | Ncontact Surgical, Inc. | accessdata.fda.gov |
| September 26, 2012 | K122611 | COOLRAIL LINEAR PEN MODEL MCRI | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| August 29, 2012 | K122276 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP | FZP | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| March 20, 2012 | K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM | OCL | Substantially Equivalent | Endoscopic Technologies, Inc. D/B/A Estech | accessdata.fda.gov |
| June 9, 2011 | K111020 | ATRICURE DISSECTOR | FTD | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| May 26, 2011 | K111042 | ATRICURE CRYO MODULE | GEH | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| April 8, 2011 | K110117 | ATRICURE BIPOLAR SYSTEM | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| June 10, 2010 | K093679 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 | FZP | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| May 6, 2009 | K090385 | LARIAT II SUTURE DELIVERY DEVICE | GAT | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| February 17, 2009 | K090202 | NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 | OCL | Substantially Equivalent | Ncontact Surgical, Inc. | accessdata.fda.gov |
| December 30, 2008 | K082203 | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 | OCL | Substantially Equivalent | Ncontact Surgical, Inc. | accessdata.fda.gov |
| August 11, 2008 | K080364 | FINDRWIRZ GUIDE WIRE SYSTEM | DQX | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| February 8, 2008 | K070126 | OCCLUSION BALLOON CATHETER | DQY | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| January 26, 2007 | K063630 | ATRICURE ABLATION SYSTEM | GEI | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| July 12, 2006 | K061593 | ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 | OCL | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| January 6, 2006 | K053326 | ESTECH COBRA ELECTROSURGICAL UNIT & CABLE | GEI | Substantially Equivalent | Endoscopic Technologies, Inc. | accessdata.fda.gov |
| June 16, 1981 | K811390 | CCS100 CRYOSURGICAL SYSTEM | GEH | Substantially Equivalent | Frigitronics of Connecticut, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 28, 2021 | P200002 | EPi-Sense Guided Coagulation System | OCM | 15 | September 24, 2026 | accessdata.fda.gov |
| December 14, 2011 | P100046 | ATRICURE SYNERGY ABLATION SYSTEM | OCM | 20 | September 24, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 28, 2023 | 93672 | Class II | Ongoing | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material. | accessdata.fda.gov |
| May 29, 2019 | 83021 | Class II | Terminated | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1c | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used. | accessdata.fda.gov |
| January 22, 2019 | 81932 | Class II | Terminated | COBRA FUSION 50, Ablation System, Catalog # (REF) | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized. | accessdata.fda.gov |
| November 30, 2016 | 76017 | Class II | Terminated | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek lid. A single-walled non- | A complaint of the PRO2 jaw breaking prior to surgery being performed. | accessdata.fda.gov |
| September 22, 2016 | 75373 | Class II | Terminated | COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers:, 700-001S, 700-001MI,, and. Intended to ablate cardiac tissue during cardiac surgery using rad | Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure. | accessdata.fda.gov |
| September 22, 2016 | 75178 | Class II | Terminated | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical proc | There is a potential for a component failure of the device which could necessitate medical intervention. | accessdata.fda.gov |
| November 21, 2014 | 69713 | Class II | Terminated | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to | Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier. | accessdata.fda.gov |
| January 23, 2014 | 67572 | Class II | Terminated | Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillin | The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. | accessdata.fda.gov |
| January 14, 2013 | 64404 | Class II | Terminated | Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary card | Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. | accessdata.fda.gov |
Compare with other makers
- All makers of Clip, Implantable
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- All makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- All makers of Device, Surgical, Cryogenic
- All makers of Left Atrial Appendage Clip, Implantable
Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.