OCL — Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue Class II
FDA product code OCL covers "Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |