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)
FDA 510(k) K221358 · AtriCure, Inc.
510(k) numberK221358
Submission
- Device name
- 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)
- Applicant
- AtriCure, Inc.
Mason, OH, US - Received
- May 11, 2022
- Decision date
- December 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCL – Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Other 510(k)s with product code OCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL · Special | AtriCure, Inc. | 07/24/2025SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | AtriCure, Inc. | 08/27/2024SE |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…OCL · Special | Medtronic, Inc. | 12/22/2022SE |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEOCL · Traditional | AtriCure, Inc. | 07/26/2021SE |
| K211311 | AtriCure Isolator® Synergy Surgical Ablation SystemOCL · Special | AtriCure, Inc. | 05/28/2021SE |
| K200514 | Cardioblate Gemini-s Surgical Ablation DeviceOCL · Traditional | Medtronic | 06/03/2020SE |
| K193162 | EPi-Sense Guided Coagulation System with VisiTraxOCL · Special | AtriCure, Inc. | 12/13/2019SE |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenOCL · Special | AtriCure, Inc. | 11/04/2019SE |
| K191526 | Cardioblate CryoFlex Surgical Ablation SystemOCL · Special | Medtronic, Inc. | 10/01/2019SE |
| K190587 | Coolrail Linear PenOCL · Special | AtriCure, Inc. | 07/24/2019SE |
More from AtriCure, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL · Special | 07/24/2025SE |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT)GXH · Traditional | 04/10/2025SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | 01/15/2025SE |
| K243157 | AtriCure cryoICE BOX (ACM)GXH · Special | 10/29/2024SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | 08/27/2024SE |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX · Traditional | 07/29/2024SE |
| K233959 | EPi-Ease Epicardial Access Device (EAS)DYB · Traditional | 02/13/2024SE |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special | 11/02/2023SE |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…GXH · Special | 10/26/2023SE |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEOCL · Traditional | 07/26/2021SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K221358) received a 510(k) decision of Substantially Equivalent on December 30, 2022, 233 days after the submission was received.
What is the product code of K221358?
The FDA product code is OCL – Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, a Class II (moderate risk) device regulated under 21 CFR 878.4400.