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 the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2021-05-28 under 510(k) 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. The listed applicant is AtriCure, Inc.. The 510(k) number is K211311.

When did AtriCure Isolator® Synergy™ Surgical Ablation System receive FDA 510(k) clearance?

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

Who is the listed applicant for AtriCure Isolator® Synergy™ Surgical Ablation System?

The FDA 510(k) record lists AtriCure, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing AtriCure, Inc. as applicant

PMA P200002Surgical cardiac ablation device, for treatment of atrial fibrillation PMA P100046Surgical cardiac ablation device, for treatment of atrial fibrillation K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)K250371cryoICE cryoXT cryoablation probe (cryoXT)K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)

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Related Devices (Code: OCL)

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.K221358Isolator® 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)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic

Official Source

View on FDA Database →

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