Atlas FDA

OCL

54 FDA 510(k) clearances · Product code

81 daysmedian time to decision
199 days90th percentile
54clearances measured

FDA profile

Official device name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
FDA definition
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Adverse events (MAUDE)
2021: 63 · 2022: 59 · 2023: 99 · 2024: 59 · 2025: 48 · 2026: 31
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056)AtriCure, Inc.2025-07-24
Isolator Synergy EnCapture Ablation System (EMH) (K234151)AtriCure, Inc.2024-08-27
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) (K221358)AtriCure, Inc.2022-12-30
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device (K223508)Medtronic, Inc.2022-12-22
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (K210477)AtriCure, Inc.2021-07-26
AtriCure Isolator® Synergy™ Surgical Ablation System (K211311)AtriCure, Inc.2021-05-28
Cardioblate Gemini-s Surgical Ablation Device (K200514)Medtronic2020-06-03
EPi-Sense Guided Coagulation System with VisiTrax (K193162)AtriCure, Inc.2019-12-13
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (K192125)AtriCure, Inc.2019-11-04
Cardioblate CryoFlex Surgical Ablation System (K191526)Medtronic, Inc.2019-10-01
Coolrail Linear Pen (K190587)AtriCure, Inc.2019-07-24
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device (K190623)Medtronic2019-05-30
COBRA Fusion Ablation System (K190151)AtriCure, Inc.2019-02-25
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device (K182610)Medtronic2018-12-19
Coolrail Linear Pen (K183065)AtriCure, Inc.2018-12-04
Isolator Multifunctional Linear Pen (K163408)AtriCure, Inc.2017-01-03
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX (K142084)Ncontact Surgical, Inc.2014-10-28
ISOLATOR LINEAR PEN (K130521)AtriCure, Inc.2013-04-05
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM (K123733)Medtronic, Inc.2013-04-01
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX (K120857)Ncontact Surgical, Inc.2012-11-13
CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES (K121878)Medtronic, Inc.2012-11-02
COOLRAIL LINEAR PEN MODEL MCRI (K122611)AtriCure, Inc.2012-09-26
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE (K121767)Medtronic, Inc.2012-07-13
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE (K121451)Medtronic, Inc.2012-06-14
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM (K113475)Endoscopic Technologies, Inc. D/B/A Estech2012-03-20
ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY (K110913)Endoscopic Technologies, Inc. D/B/A Estech2011-09-23
ATRICURE BIPOLAR SYSTEM (K110117)AtriCure, Inc.2011-04-08
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 (K101174)AtriCure, Inc.2010-11-12
MULTIFUNCTIONAL LINEAR PEN (K100501)AtriCure, Inc.2010-06-18
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 (K090721)Medtronic2009-06-16
NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 (K090202)Ncontact Surgical, Inc.2009-02-17
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 (K082203)Ncontact Surgical, Inc.2008-12-30
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 (K082279)St Jude Medical2008-09-16
EPICOR ABLATION SYSTEM (K080292)St Jude Medical2008-07-25
CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE (K080509)Medtronic, Inc.2008-05-05
ATRICURE COOLRAIL LINEAR PEN (K073605)AtriCure, Inc.2008-03-11
NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 (K071819)Ncontact Surgical, Inc.2007-07-26
ATRICURE BIPOLAR SYSTEM (K043579)AtriCure, Inc.2007-07-05
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 (K070288)Medtronic Vascular2007-06-18
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK (K063012)Ncontact Surgical, Inc.2006-12-01
SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 (K062140)Cryocath Technologies, Inc.2006-08-24
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 (K061593)AtriCure, Inc.2006-07-12
MODIFICATION TO: CARDIMA ABLATION SYSTEM (K060715)Cardima, Inc.2006-05-15
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE (K053436)Cryocath Technologies, Inc.2006-01-13
ATRICURE ISOLATOR TRANSPOLAR PEN (K050459)AtriCure, Inc.2005-06-13
CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 (K041890)Cryocor, Inc.2004-09-22
SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE (K040690)Cryocath Technologies, Inc.2004-04-29
CARDIMA ABLATION SYSTEM (K022008)Cardima, Inc.2003-01-29
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE (K021010)Endocare, Inc.2002-06-06
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 (K013392)Medtronic Vascular2002-01-25
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C (K011988)Cardiofocus, Inc.2001-09-20
CRYOCARE CARDIAC SURGICAL SYSTEM (K011040)Endocare, Inc.2001-06-15
CRYOGEN CARDIAC CRYOSURGICAL SYSTEM (K974320)Cryogen, Inc.1998-02-03
HEARTPORT MAZE SYSTEM: CRYOPROBE SET (K970496)Heartport, Inc.1997-05-09

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Every clearance here is in the API, with alerts when new ones post.