Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2
FDA 510(k) K101174 · AtriCure, Inc.
510(k) numberK101174
Submission
- Device name
- Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2
- Applicant
- AtriCure, Inc.
West Chester, OH, US - Received
- April 27, 2010
- Decision date
- November 12, 2010
- 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 |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | AtriCure, Inc. | 12/30/2022SE |
| 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 |
More from Medtronic, 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 |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | 12/30/2022SE |
Questions and answers
When was Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2 cleared by the FDA?
Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2 (K101174) received a 510(k) decision of Substantially Equivalent on November 12, 2010, 199 days after the submission was received.
What is the product code of K101174?
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.