Panels › General, Plastic Surgery › Product code OCL · Class 2
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Regulation 878.4400
0510(k)s in 12 months (54 all time)
0recalls in 12 months (17 all time)
17recalls that name a 510(k)
Top companies in OCL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2025 | K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) AtriCure, Inc. | OCL |
| Aug 27, 2024 | K234151 | Isolator Synergy EnCapture Ablation System (EMH) AtriCure, Inc. | OCL |
| Dec 30, 2022 | K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surg AtriCure, Inc. | OCL |
| Dec 22, 2022 | K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device Medtronic, 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 |
| Jun 3, 2020 | K200514 | Cardioblate Gemini-s Surgical Ablation Device Medtronic | OCL |
| 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 |
| Oct 1, 2019 | K191526 | Cardioblate CryoFlex Surgical Ablation System Medtronic, Inc. | OCL |
| Jul 24, 2019 | K190587 | Coolrail Linear Pen AtriCure, Inc. | OCL |
| May 30, 2019 | K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device Medtronic | OCL |
| Feb 25, 2019 | K190151 | COBRA Fusion Ablation System AtriCure, Inc. | OCL |
| Dec 19, 2018 | K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Devi Medtronic | OCL |
| Dec 4, 2018 | K183065 | Coolrail Linear Pen AtriCure, Inc. | OCL |
| Jan 3, 2017 | K163408 | Isolator Multifunctional Linear Pen AtriCure, Inc. | OCL |
| Oct 28, 2014 | K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX Ncontact Surgical, Inc. | OCL |
| Apr 5, 2013 | K130521 | ISOLATOR LINEAR PEN AtriCure, Inc. | OCL |
| Apr 1, 2013 | K123733 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM Medtronic, Inc. | OCL |
| Nov 13, 2012 | K120857 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX Ncontact Surgical, Inc. | OCL |
| Nov 2, 2012 | K121878 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES Medtronic, Inc. | OCL |
| Sep 26, 2012 | K122611 | COOLRAIL LINEAR PEN MODEL MCRI AtriCure, Inc. | OCL |
| Jul 13, 2012 | K121767 | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE Medtronic, Inc. | OCL |
| Jun 14, 2012 | K121451 | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE Medtronic, Inc. | OCL |
| Mar 20, 2012 | K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM Endoscopic Technologies, Inc. D/B/A Estech | OCL |
| Sep 23, 2011 | K110913 | ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY Endoscopic Technologies, Inc. D/B/A Estech | OCL |
| 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 16, 2009 | K090721 | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 Medtronic | OCL |
| Feb 17, 2009 | K090202 | NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 Ncontact Surgical, Inc. | OCL |
| Dec 30, 2008 | K082203 | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 Ncontact Surgical, Inc. | OCL |
| Sep 16, 2008 | K082279 | EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 St Jude Medical | OCL |
| Jul 25, 2008 | K080292 | EPICOR ABLATION SYSTEM St Jude Medical | OCL |
| May 5, 2008 | K080509 | CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE Medtronic, Inc. | OCL |
| Mar 11, 2008 | K073605 | ATRICURE COOLRAIL LINEAR PEN AtriCure, Inc. | OCL |
| Jul 26, 2007 | K071819 | NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 Ncontact Surgical, Inc. | OCL |
| Jul 5, 2007 | K043579 | ATRICURE BIPOLAR SYSTEM AtriCure, Inc. | OCL |
| Jun 18, 2007 | K070288 | CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 Medtronic Vascular | OCL |
| Dec 1, 2006 | K063012 | NCONTACT COAGULATION SYSTEM KIT, MODEL CSK Ncontact Surgical, Inc. | OCL |
| Aug 24, 2006 | K062140 | SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 Cryocath Technologies, Inc. | OCL |
| Jul 12, 2006 | K061593 | ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 AtriCure, Inc. | OCL |
| May 15, 2006 | K060715 | MODIFICATION TO: CARDIMA ABLATION SYSTEM Cardima, Inc. | OCL |
| Jan 13, 2006 | K053436 | SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE Cryocath Technologies, Inc. | OCL |
| Jun 13, 2005 | K050459 | ATRICURE ISOLATOR TRANSPOLAR PEN AtriCure, Inc. | OCL |
| Sep 22, 2004 | K041890 | CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 Cryocor, Inc. | OCL |
| Apr 29, 2004 | K040690 | SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE Cryocath Technologies, Inc., CA | OCL |
| Jan 29, 2003 | K022008 | CARDIMA ABLATION SYSTEM Cardima, Inc. | OCL |
| Jun 6, 2002 | K021010 | MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE Endocare, Inc. | OCL |
| Jan 25, 2002 | K013392 | CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 Medtronic Vascular | OCL |
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