Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
FDA 510(k) K192125 · AtriCure, Inc.
510(k) numberK192125
Submission
- Device name
- Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
- Applicant
- AtriCure, Inc.
Mason, OH, US - Received
- August 6, 2019
- Decision date
- November 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | 12/30/2022SE |
Questions and answers
When was Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen cleared by the FDA?
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (K192125) received a 510(k) decision of Substantially Equivalent on November 4, 2019, 90 days after the submission was received.
What is the product code of K192125?
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.