Company · US
AtriCure, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2026. Name variants (Inc, Corp, punctuation) are merged.
60510(k) clearances (1 in 12 months)
13recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 27 |
| FZP | Clip, Implantable | 13 |
| GEH | Unit, Cryosurgical, Accessories | 11 |
| GXH | Device, Surgical, Cryogenic | 7 |
| PZX | Left Atrial Appendage Clip, Implantable | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| FTD | Lamp, Surgical | 2 |
| DYB | Introducer, Catheter | 1 |
| HBT | Applier, Hemostatic Clip | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K263319 | ACHM30 AtriClip FLEX-Mini LAA Exclusion System AtriCure, Inc. | PZX |
| Jul 24, 2025 | K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) AtriCure, Inc. | OCL |
| Apr 10, 2025 | K250371 | cryoICE cryoXT cryoablation probe (cryoXT) AtriCure, Inc. | GXH |
| Jan 15, 2025 | K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) AtriCure, Inc. | PZX |
| Oct 29, 2024 | K243157 | AtriCure cryoICE BOX (ACM) AtriCure, Inc. | GXH |
| Aug 27, 2024 | K234151 | Isolator Synergy EnCapture Ablation System (EMH) AtriCure, Inc. | OCL |
| Jul 29, 2024 | K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) AtriCure, Inc. | PZX |
| Feb 13, 2024 | K233959 | EPi-Ease Epicardial Access Device (EAS) AtriCure, Inc. | DYB |
| Nov 2, 2023 | K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded AtriCure, Inc. | PZX |
| Oct 26, 2023 | K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE M AtriCure, Inc. | GXH |
| Dec 30, 2022 | K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surg AtriCure, Inc. | OCL |
| Jul 26, 2021 | K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE AtriCure, Inc. | OCL |
| May 28, 2021 | K211311 | AtriCure Isolator® Synergy Surgical Ablation System AtriCure, Inc. | OCL |
| Mar 3, 2021 | K210293 | AtriClip LAA Exclusion System AtriCure, Inc. | PZX |
| Dec 23, 2020 | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) AtriCure, Inc. | GXH |
| Dec 13, 2019 | K193162 | EPi-Sense Guided Coagulation System with VisiTrax AtriCure, Inc. | OCL |
| Nov 4, 2019 | K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen AtriCure, Inc. | OCL |
| Aug 21, 2019 | K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip AtriCure, Inc. | PZX |
| Jul 24, 2019 | K190587 | Coolrail Linear Pen AtriCure, Inc. | OCL |
| Feb 25, 2019 | K190151 | COBRA Fusion Ablation System AtriCure, Inc. | OCL |
| Dec 4, 2018 | K183065 | Coolrail Linear Pen AtriCure, Inc. | OCL |
| Nov 9, 2018 | K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe AtriCure, Inc. | GXH |
| Jun 28, 2018 | K181474 | ArtiClip LAA Exclusion System AtriCure, Inc. | PZX |
| Feb 15, 2018 | K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) AtriCure, Inc. | GXH |
| Feb 15, 2018 | K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc. | GEH |
| Jan 31, 2018 | K180010 | AtriClip FLEX-V AtriCure, Inc. | FZP |
| Oct 25, 2017 | K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V Clip AtriCure, Inc. | FZP |
| Oct 11, 2017 | K172742 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) AtriCure, Inc. | FZP |
| May 19, 2017 | K163261 | AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip AtriCure, Inc. | FZP |
| Jan 3, 2017 | K163408 | Isolator Multifunctional Linear Pen AtriCure, Inc. | OCL |
| Mar 22, 2016 | K152337 | cryoFORM cryoICE cryoablation probe AtriCure, Inc. | GEH |
| Mar 18, 2016 | K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip AtriCure, Inc. | FZP |
| Jan 27, 2016 | K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip AtriCure, Inc. | FZP |
| Jun 17, 2015 | K150996 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip AtriCure, Inc. | FZP |
| Nov 25, 2014 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe AtriCure, Inc. | GXH |
| Oct 29, 2014 | K142441 | cryoICE croablation probe AtriCure, Inc. | GEH |
| Aug 28, 2014 | K142120 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP AtriCure, Inc. | FZP |
| Jan 24, 2014 | K140058 | ATRICURE CRYO MODULE SYSTEM AtriCure, Inc. | GEH |
| May 14, 2013 | K131107 | ATRICLIP GILLINOV-COSGROVE LAA CLIP AtriCure, Inc. | FZP |
| Apr 5, 2013 | K130521 | ISOLATOR LINEAR PEN AtriCure, Inc. | OCL |
| Sep 26, 2012 | K122611 | COOLRAIL LINEAR PEN MODEL MCRI AtriCure, Inc. | OCL |
| Aug 29, 2012 | K122276 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP AtriCure, Inc. | FZP |
| Jun 6, 2012 | K121507 | ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) AtriCure, Inc. | GEH |
| Aug 3, 2011 | K112072 | ATRICURE CRYO MODULE SYSTEM AtriCure, Inc. | GEH |
| Jun 9, 2011 | K111020 | ATRICURE DISSECTOR AtriCure, Inc. | FTD |
| May 26, 2011 | K111042 | ATRICURE CRYO MODULE AtriCure, Inc. | GEH |
| Apr 8, 2011 | K110117 | ATRICURE BIPOLAR SYSTEM AtriCure, Inc. | OCL |
| Nov 12, 2010 | K101174 | ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 AtriCure, Inc. | OCL |
| Jun 18, 2010 | K100501 | MULTIFUNCTIONAL LINEAR PEN AtriCure, Inc. | OCL |
| Jun 10, 2010 | K093679 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 AtriCure, Inc. | FZP |
Newest 50 of 60.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | AtriCure, Inc. Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 Open, Classified |
GEH | K140058 |
| Jan 31, 2024 | AtriCure, Inc. Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 Open, Classified |
GEH | K140058 |
| May 29, 2019 | AtriCure, Inc. 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 Terminated |
OCL | K142084 |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI Terminated |
OCL | K113475 |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S Terminated |
OCL | K113475 |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 Terminated |
OCL | K113475 |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 Terminated |
OCL | K113475 |
| Nov 30, 2016 | AtriCure, Inc. 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. Terminated |
FZP | K160454 |
| Sep 22, 2016 | AtriCure, Inc. COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003.
Intended to ablate c Terminated |
OCL | K113475 |
| Sep 22, 2016 | AtriCure, Inc. 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 c Terminated |
FZP | K160454 |
| Dec 30, 2014 | Atricure Inc 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 u Terminated |
GEH | K082074 |
| Mar 14, 2014 | Atricure Inc 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 Cl Terminated |
HBT | None listed |
| Mar 6, 2013 | Atricure Inc 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 Uni Terminated |
OCL | K050459 K061593 |