Product code OCL
- Device name
- Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4400
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252056 | Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | 2025-07-24 |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | 2024-08-27 |
| 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 ... | AtriCure, Inc. | 2022-12-30 |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | Medtronic, Inc. | 2022-12-22 |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | 2021-07-26 |
| K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | AtriCure, Inc. | 2021-05-28 |
| K200514 | Cardioblate Gemini-s Surgical Ablation Device | Medtronic | 2020-06-03 |
| K193162 | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, Inc. | 2019-12-13 |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | 2019-11-04 |
| K191526 | Cardioblate CryoFlex Surgical Ablation System | Medtronic, Inc. | 2019-10-01 |
| K190587 | Coolrail Linear Pen | AtriCure, Inc. | 2019-07-24 |
| K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | Medtronic | 2019-05-30 |
| K190151 | COBRA Fusion Ablation System | AtriCure, Inc. | 2019-02-25 |
| K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | Medtronic | 2018-12-19 |
| K183065 | Coolrail Linear Pen | AtriCure, Inc. | 2018-12-04 |
| K163408 | Isolator Multifunctional Linear Pen | AtriCure, Inc. | 2017-01-03 |
| K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | 2014-10-28 |
| K130521 | ISOLATOR LINEAR PEN | AtriCure, Inc. | 2013-04-05 |
| K123733 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM | Medtronic, Inc. | 2013-04-01 |
| K120857 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | 2012-11-13 |
| K121878 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES | Medtronic, Inc. | 2012-11-02 |
| K122611 | COOLRAIL LINEAR PEN MODEL MCRI | AtriCure, Inc. | 2012-09-26 |
| K121767 | CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE | Medtronic, Inc. | 2012-07-13 |
| K121451 | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE | Medtronic, Inc. | 2012-06-14 |
| K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM | Endoscopic Technologies, Inc. D/B/A Estech | 2012-03-20 |
| K110913 | ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY | Endoscopic Technologies, Inc. D/B/A Estech | 2011-09-23 |
| K110117 | ATRICURE BIPOLAR SYSTEM | AtriCure, Inc. | 2011-04-08 |
| K101174 | ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 | AtriCure, Inc. | 2010-11-12 |
| K100501 | MULTIFUNCTIONAL LINEAR PEN | AtriCure, Inc. | 2010-06-18 |
| K090721 | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 | Medtronic | 2009-06-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199150027521 | Cardioblate™ | MEDTRONIC, INC. | 2026-01-16 |
| 00199150027538 | Cardioblate™ | MEDTRONIC, INC. | 2026-01-16 |
| 00763000841607 | Cardioblate™ Gemini™-s | MEDTRONIC, INC. | 2025-05-18 |
| 10884521851566 | Valleylab | Covidien LP | 2025-05-12 |
| 10840143911767 | AtriCure Isolator Synergy EnCapture Clamp | ATRICURE, INC. | 2025-03-14 |
| 30840143911761 | AtriCure Isolator Synergy EnCapture Clamp | ATRICURE, INC. | 2025-03-14 |
| 10884521829527 | Valleylab | Covidien LP | 2024-10-03 |
| 10884521829534 | Valleylab | Covidien LP | 2024-10-03 |
| 00763000841591 | Cardioblate™ Gemini™-s | MEDTRONIC, INC. | 2024-04-28 |
| 10840143905834 | AtriCure Isolator Synergy Clamp and Guide System | ATRICURE, INC. | 2023-02-07 |
| 30840143904817 | AtriCure Isolator Synergy EnCompass Clamp and Guide System | ATRICURE, INC. | 2023-02-07 |
| 10840143905995 | AtriCure Isolator Synergy EnCompass Clamp and Guide System | ATRICURE, INC. | 2023-02-07 |
| 30840143904114 | AtriCure Isolator Synergy Clamp and Guide System | ATRICURE, INC. | 2023-01-04 |
| 10840143905209 | AtriCure Isolator Synergy EnCompass Clamp and Guide System | ATRICURE, INC. | 2023-01-04 |
| 10840143905193 | AtriCure Isolator Synergy Clamp and Guide System | ATRICURE, INC. | 2023-01-04 |
| 10840143905520 | AtriCure Isolator Synergy EnCompass Clamp and Guide System | ATRICURE, INC. | 2023-01-04 |
| 00810563020953 | 8mm Cryoprobe | VARIAN MEDICAL SYSTEMS, INC. | 2022-02-18 |
| 10840143904134 | AtriCure Isolator Synergy EnCompass Clamp and GuideSystem | ATRICURE, INC. | 2021-08-12 |
| 10840143902574 | Isolator Surgical Ablation System | ATRICURE, INC. | 2021-01-11 |
| 10840143902253 | Isolator Surgical Ablation System | ATRICURE, INC. | 2021-01-11 |
| 10840143902222 | Isolator Surgical Ablation System | ATRICURE, INC. | 2021-01-11 |
| 10840143902161 | Isolator Surgical Ablation System | ATRICURE, INC. | 2021-01-11 |
| 10840143901454 | nContact RF Generator | ATRICURE, INC. | 2021-01-11 |
| 10840143902260 | Isolator Surgical Ablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143901980 | Isolator Surgical Ablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143900402 | Isolator Surgical Ablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143900372 | Fusion Ablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143900358 | Fusion Ablation System | ATRICURE, INC. | 2021-01-08 |
| 10840143900341 | EPi-Sense Guided Coagulation System with VisiTrax | ATRICURE, INC. | 2021-01-08 |
| 10840143900327 | EPi-Sense Guided Coagulation System with VisiTrax | ATRICURE, INC. | 2021-01-08 |