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Certus 140 Microwave Ablation System And Accessories, Model Certus 140

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100744

by NeuWave Medical, Inc.

Identifiers

510(k) Number
K100744 FDA 510(k)
FDA Product Code
NEY 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 Certus 140 Microwave Ablation System And Accessories, Model Certus 140, is a microwave ablation system indicated for the ablation of soft tissue in various surgical settings, including percutaneous, open surgical, and laparoscopic surgical settings. It is used for the coagulation of soft tissue. The system operates at a frequency of 2.45 GHz.

The Certus 140 Microwave Ablation System And Accessories, Model Certus 140, is supplied with a user reference manual and is authorized with FDA 510K clearance. The system is used in general and plastic surgery settings, and its regulation number is 878.4400. The device is manufactured by NeuWave Medical, Inc.

Frequently asked questions

What is the Certus 140 Microwave Ablation System used for?

The Certus 140 Microwave Ablation System is used for the ablation of soft tissue in various surgical settings, including percutaneous, open surgical, and laparoscopic surgical settings, and for the coagulation of soft tissue.

What frequency does the Certus 140 Microwave Ablation System operate at?

The Certus 140 Microwave Ablation System operates at a frequency of 2.45 GHz.

Is the Certus 140 Microwave Ablation System supplied with any documentation?

Yes, the Certus 140 Microwave Ablation System is supplied with a user reference manual.

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: PDF 2.45 GHz Ablation System User Reference Manual, NeuWave Medical Certus 140 User's Reference Manual, Neuwave medical Certus 140 Manuals | ManualsLib, Products | NeuWave Microwave Ablation | NeuWave Medical, Inc., PDF NEUWAVE™ Microwave Ablation System User Reference Manu

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
NeuWave Medical, Inc.

Sources (1)

  • FDA 510(k) K100744 24 fields · synced Sep 28, 2026