FDA Product Code
FDA Product Code OCL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 54 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | 2025-07-24 | Special | PDF ↗ |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | 2024-08-27 | Traditional | PDF ↗ |
| 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) | AtriCure, Inc. | 2022-12-30 | Traditional | PDF ↗ |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | Medtronic, Inc. | 2022-12-22 | Special | PDF ↗ |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | 2021-07-26 | Traditional | PDF ↗ |
| K211311 | AtriCure Isolator® Synergy Surgical Ablation System | AtriCure, Inc. | 2021-05-28 | Special | PDF ↗ |
| K200514 | Cardioblate Gemini-s Surgical Ablation Device | Medtronic | 2020-06-03 | Traditional | PDF ↗ |
| K193162 | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, Inc. | 2019-12-13 | Special | PDF ↗ |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | 2019-11-04 | Special | PDF ↗ |
| K191526 | Cardioblate CryoFlex Surgical Ablation System | Medtronic, Inc. | 2019-10-01 | Special | PDF ↗ |
| K190587 | Coolrail Linear Pen | AtriCure, Inc. | 2019-07-24 | Special | PDF ↗ |
| K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | Medtronic | 2019-05-30 | Traditional | PDF ↗ |
| K190151 | COBRA Fusion Ablation System | AtriCure, Inc. | 2019-02-25 | Special | PDF ↗ |
| K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | Medtronic | 2018-12-19 | Traditional | PDF ↗ |
| K183065 | Coolrail Linear Pen | AtriCure, Inc. | 2018-12-04 | Special | PDF ↗ |
| K163408 | Isolator Multifunctional Linear Pen | AtriCure, Inc. | 2017-01-03 | Special | PDF ↗ |
| K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | 2014-10-28 | Traditional | PDF ↗ |
| K130521 | ISOLATOR LINEAR PEN | AtriCure, Inc. | 2013-04-05 | Special | PDF ↗ |
| K123733 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM | Medtronic, Inc. | 2013-04-01 | Traditional | PDF ↗ |
| K120857 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | 2012-11-13 | Traditional | PDF ↗ |
| K121878 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES | Medtronic, Inc. | 2012-11-02 | Special | PDF ↗ |
| K122611 | COOLRAIL LINEAR PEN MODEL MCRI | AtriCure, Inc. | 2012-09-26 | Special | PDF ↗ |
| K121767 | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE | Medtronic, Inc. | 2012-07-13 | Special | PDF ↗ |
| K121451 | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE | Medtronic, Inc. | 2012-06-14 | Special | PDF ↗ |
| K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM | Endoscopic Technologies, Inc. D/B/A Estech | 2012-03-20 | Traditional | PDF ↗ |
| K110913 | ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY | Endoscopic Technologies, Inc. D/B/A Estech | 2011-09-23 | Special | PDF ↗ |
| K110117 | ATRICURE BIPOLAR SYSTEM | AtriCure, Inc. | 2011-04-08 | Traditional | PDF ↗ |
| K101174 | ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 | AtriCure, Inc. | 2010-11-12 | Traditional | PDF ↗ |
| K100501 | MULTIFUNCTIONAL LINEAR PEN | AtriCure, Inc. | 2010-06-18 | Traditional | PDF ↗ |
| K090721 | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 | Medtronic | 2009-06-16 | Traditional | PDF ↗ |
| K090202 | NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 | Ncontact Surgical, Inc. | 2009-02-17 | Special | PDF ↗ |
| K082203 | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 | Ncontact Surgical, Inc. | 2008-12-30 | Special | PDF ↗ |
| K082279 | EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 | St Jude Medical | 2008-09-16 | Special | PDF ↗ |
| K080292 | EPICOR ABLATION SYSTEM | St Jude Medical | 2008-07-25 | Special | PDF ↗ |
| K080509 | CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE | Medtronic, Inc. | 2008-05-05 | Traditional | PDF ↗ |
| K073605 | ATRICURE COOLRAIL LINEAR PEN | AtriCure, Inc. | 2008-03-11 | Traditional | PDF ↗ |
| K071819 | NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 | Ncontact Surgical, Inc. | 2007-07-26 | Special | PDF ↗ |
| K043579 | ATRICURE BIPOLAR SYSTEM | AtriCure, Inc. | 2007-07-05 | Traditional | PDF ↗ |
| K070288 | CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 | Medtronic Vascular | 2007-06-18 | Traditional | PDF ↗ |
| K063012 | NCONTACT COAGULATION SYSTEM KIT, MODEL CSK | Ncontact Surgical, Inc. | 2006-12-01 | Traditional | PDF ↗ |
| K062140 | SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 | Cryocath Technologies, Inc. | 2006-08-24 | Special | PDF ↗ |
| K061593 | ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 | AtriCure, Inc. | 2006-07-12 | Traditional | PDF ↗ |
| K060715 | MODIFICATION TO: CARDIMA ABLATION SYSTEM | Cardima, Inc. | 2006-05-15 | Special | PDF ↗ |
| K053436 | SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE | Cryocath Technologies, Inc. | 2006-01-13 | Special | PDF ↗ |
| K050459 | ATRICURE ISOLATOR TRANSPOLAR PEN | AtriCure, Inc. | 2005-06-13 | Traditional | PDF ↗ |
| K041890 | CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 | Cryocor, Inc. | 2004-09-22 | Traditional | PDF ↗ |
| K040690 | SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE | Cryocath Technologies, Inc. | 2004-04-29 | Special | PDF ↗ |
| K022008 | CARDIMA ABLATION SYSTEM | Cardima, Inc. | 2003-01-29 | Traditional | PDF ↗ |
| K021010 | MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE | Endocare, Inc. | 2002-06-06 | Special | PDF ↗ |
| K013392 | CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 | Medtronic Vascular | 2002-01-25 | Abbreviated | PDF ↗ |
| K011988 | SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C | Cardiofocus, Inc. | 2001-09-20 | Traditional | PDF ↗ |
| K011040 | CRYOCARE CARDIAC SURGICAL SYSTEM | Endocare, Inc. | 2001-06-15 | Traditional | PDF ↗ |
| K974320 | CRYOGEN CARDIAC CRYOSURGICAL SYSTEM | Cryogen, Inc. | 1998-02-03 | Traditional | PDF ↗ |
| K970496 | HEARTPORT MAZE SYSTEM: CRYOPROBE SET | Heartport, Inc. | 1997-05-09 | Traditional | PDF ↗ |
Product code OCL · Class II · General, Plastic Surgery. Data: openFDA.