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FDA 510(k)

Isolator Multifunctional Linear Pen

K-Number: K163408 · 2017-01-03

ApplicantAtriCure, Inc.
Decision Date2017-01-03
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Isolator Multifunctional Linear Pen is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2017-01-03 under approval number K163408. 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 Isolator Multifunctional Linear Pen?

Isolator Multifunctional Linear Pen is a medical device that received FDA 510(k) clearance on 2017-01-03. It is manufactured by AtriCure, Inc.. The 510(k) number is K163408.

When was Isolator Multifunctional Linear Pen approved by the FDA?

Isolator Multifunctional Linear Pen received FDA 510(k) clearance on 2017-01-03, under approval number K163408.

What company makes Isolator Multifunctional Linear Pen?

Isolator Multifunctional Linear Pen is manufactured by AtriCure, Inc..

What is the FDA product code for Isolator Multifunctional Linear Pen?

The FDA product code for Isolator Multifunctional Linear Pen is OCL.

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Related Devices (Code: OCL)

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. K190587Coolrail Linear PenAtriCure, Inc.

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.

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