Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → OCL — Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue # OCL · Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue _General, Plastic Surgery · 21 CFR 878.4400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL ## Overview - **Product Code:** OCL - **Device Name:** Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue - **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K252056.md) | Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | Jul 24, 2025 | SESE | | [K234151](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K234151.md) | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | Aug 27, 2024 | SESE | | [K221358](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K221358.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K223508.md) | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | Medtronic, Inc. | Dec 22, 2022 | SESE | | [K210477](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K210477.md) | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | Jul 26, 2021 | SESE | | [K211311](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K211311.md) | AtriCure Isolator® Synergy™ Surgical Ablation System | AtriCure, Inc. | May 28, 2021 | SESE | | [K200514](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K200514.md) | Cardioblate Gemini-s Surgical Ablation Device | Medtronic | Jun 3, 2020 | SESE | | [K193162](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K193162.md) | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, Inc. | Dec 13, 2019 | SESE | | [K192125](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K192125.md) | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | Nov 4, 2019 | SESE | | [K191526](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K191526.md) | Cardioblate CryoFlex Surgical Ablation System | Medtronic, Inc. | Oct 1, 2019 | SESE | | [K190587](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K190587.md) | Coolrail Linear Pen | AtriCure, Inc. | Jul 24, 2019 | SESE | | [K190623](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K190623.md) | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | Medtronic | May 30, 2019 | SESE | | [K190151](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K190151.md) | COBRA Fusion Ablation System | AtriCure, Inc. | Feb 25, 2019 | SESE | | [K182610](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K182610.md) | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | Medtronic | Dec 19, 2018 | SESE | | [K183065](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K183065.md) | Coolrail Linear Pen | AtriCure, Inc. | Dec 4, 2018 | SESE | | [K163408](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K163408.md) | Isolator Multifunctional Linear Pen | AtriCure, Inc. | Jan 3, 2017 | SESE | | [K142084](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K142084.md) | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | Ncontact Surgical, Inc. | Oct 28, 2014 | SESE | | [K130521](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K130521.md) | ISOLATOR LINEAR PEN | AtriCure, Inc. | Apr 5, 2013 | SESE | | [K123733](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K123733.md) | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM | Medtronic, Inc. | Apr 1, 2013 | SESE | | [K120857](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL/K120857.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com