OCL · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | OCL |
|---|---|
| Device Name | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 54)
Showing 20 most recent of 54 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | Jul 24, 2025 | SESE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | Aug 27, 2024 | SESE |
| 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. | Dec 30, 2022 | SESE |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | Medtronic, Inc. | Dec 22, 2022 | SESE |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | Jul 26, 2021 | SESE |
| K211311 | AtriCure Isolator® Synergy Surgical Ablation System | AtriCure, Inc. | May 28, 2021 | SESE |
| K200514 | Cardioblate Gemini-s Surgical Ablation Device | Medtronic | Jun 3, 2020 | SESE |
| K193162 | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, Inc. | Dec 13, 2019 | SESE |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | Nov 4, 2019 | SESE |
| K191526 | Cardioblate CryoFlex Surgical Ablation System | Medtronic, Inc. | Oct 1, 2019 | SESE |
| K190587 | Coolrail Linear Pen | AtriCure, Inc. | Jul 24, 2019 | SESE |
| K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | Medtronic | May 30, 2019 | SESE |
| K190151 | COBRA Fusion Ablation System | AtriCure, Inc. | Feb 25, 2019 | SESE |
| K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | Medtronic | Dec 19, 2018 | SESE |
| K183065 | Coolrail Linear Pen | AtriCure, Inc. | Dec 4, 2018 | SESE |
| K163408 | Isolator Multifunctional Linear Pen | AtriCure, Inc. | Jan 3, 2017 | SESE |
| K142084 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | Oct 28, 2014 | SESE |
| K130521 | ISOLATOR LINEAR PEN | AtriCure, Inc. | Apr 5, 2013 | SESE |
| K123733 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM | Medtronic, Inc. | Apr 1, 2013 | SESE |
| K120857 | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | Nov 13, 2012 | SESE |
Top Applicants
- AtriCure, Inc. — 20 clearances
- Medtronic, Inc. — 7 clearances
- Ncontact Surgical, Inc. — 6 clearances
- Medtronic — 4 clearances
- Cryocath Technologies, Inc. — 3 clearances
