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AtriCure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101174

by Atricure, Inc.

Identifiers

510(k) Number
K101174 FDA 510(k)
FDA Product Code
OCL FDA 510(k)
Models / Variants
Oll2 FDA 510(k)
Osl2 FDA 510(k)
Emr2 FDA 510(k)
Eml2 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue. It is a bipolar system that includes Isolator Synergy dual electrode clamps in models OLL2, OSL2, EMR2, and EML2.

It is supplied as a surgical ablation device with FDA 510(k) authorization under product code OCL and regulation number 878.4400. The device is intended for use in general and plastic surgery settings, with no claims made regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or additional authorizations beyond those explicitly stated.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Isolator Synergy & Bipolar RF Ablation Clamps | AtriCure, Isolator Synergy Clamps | EML2 and EMR2 | AtriCure, Isolator Synergy & Bipolar RF Ablation Clamps | AtriCure, Atricure Bipolar System Including Isolator Synergy Dual Electrode ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA 510(k) K101174 24 fields · synced Sep 22, 2026