FDA 510(k)

AtriCure Isolator® Synergy Surgical Ablation System

K-Number: K211311 · 2021-05-28

Decision Date2021-05-28

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AtriCure Isolator® Synergy Surgical Ablation System is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2021-05-28 under approval number K211311. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AtriCure Isolator® Synergy Surgical Ablation System?

AtriCure Isolator® Synergy Surgical Ablation System is a medical device that received FDA 510(k) clearance on 2021-05-28. It is manufactured by AtriCure, Inc.. The 510(k) number is K211311.

When was AtriCure Isolator® Synergy Surgical Ablation System approved by the FDA?

AtriCure Isolator® Synergy Surgical Ablation System received FDA 510(k) clearance on 2021-05-28, under approval number K211311.

What company makes AtriCure Isolator® Synergy Surgical Ablation System?

AtriCure Isolator® Synergy Surgical Ablation System is manufactured by AtriCure, Inc..

What is the FDA product code for AtriCure Isolator® Synergy Surgical Ablation System?

The FDA product code for AtriCure Isolator® Synergy Surgical Ablation System is OCL.

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Related PubMed Literature

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Related Devices (Code: OCL)

K163408Isolator Multifunctional Linear PenAtriCure, Inc. K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation DeviceMedtronic K183065Coolrail Linear PenAtriCure, Inc. K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc. K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc. K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.