OCL — Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue Class II
Classification Details
- Product Code
- OCL
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- CV
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252056 | atricure | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | July 24, 2025 |
| K234151 | atricure | Isolator Synergy EnCapture Ablation System (EMH) | August 27, 2024 |
| K221358 | atricure | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® L | December 30, 2022 |
| K223508 | medtronic | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 | December 22, 2022 |
| K210477 | atricure | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | July 26, 2021 |
| K211311 | atricure | AtriCure Isolator® Synergy Surgical Ablation System | May 28, 2021 |
| K200514 | medtronic | Cardioblate Gemini-s Surgical Ablation Device | June 3, 2020 |
| K193162 | atricure | EPi-Sense Guided Coagulation System with VisiTrax | December 13, 2019 |
| K192125 | atricure | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | November 4, 2019 |
| K191526 | medtronic | Cardioblate CryoFlex Surgical Ablation System | October 1, 2019 |
| K190587 | atricure | Coolrail Linear Pen | July 24, 2019 |
| K190623 | medtronic | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation D | May 30, 2019 |
| K190151 | atricure | COBRA Fusion Ablation System | February 25, 2019 |
| K182610 | medtronic | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Devic | December 19, 2018 |
| K183065 | atricure | Coolrail Linear Pen | December 4, 2018 |
| K163408 | atricure | Isolator Multifunctional Linear Pen | January 3, 2017 |
| K142084 | ncontact surgical | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | October 28, 2014 |
| K130521 | atricure | ISOLATOR LINEAR PEN | April 5, 2013 |
| K123733 | medtronic | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM | April 1, 2013 |
| K120857 | ncontact surgical | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX | November 13, 2012 |