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Valleylab Microwave Ablation Generator

by Covidien Lp, Formerly Know AS Valleylab, A Divison

510(k) K072687

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072687 Date25 Nov 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Valleylab Microwave Ablation Generator is a system for ablation using microwave energy. It is designed for the ablation of soft tissue, including partial or complete ablation of non-resectable liver tumors. The device is used in percutaneous, laparoscopic, and intraoperative coagulation procedures.

The Valleylab Microwave Ablation Generator is supplied with a product code of NEY and is classified as a class 2 device. It has an FDA 510K authorization, with a regulation number of 878.4400 and a k number of K072687. The device is intended for use in image-guided tumor ablation procedures.

Other devices from Covidien Lp, Formerly Know AS Valleylab, A Divison

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Valleylab Microwave Ablation Generator used for?

    The Valleylab Microwave Ablation Generator is used for the ablation of soft tissue, including partial or complete ablation of non-resectable liver tumors, in percutaneous, laparoscopic, and intraoperative coagulation procedures.

  • What type of procedures can the Valleylab Microwave Ablation Generator be used in?

    The device can be used in image-guided tumor ablation procedures, including percutaneous, laparoscopic, and intraoperative coagulation procedures.

  • What is the regulatory status of the Valleylab Microwave Ablation Generator?

    The Valleylab Microwave Ablation Generator has an FDA 510K authorization, with a regulation number of 878.4400 and a k number of K072687, indicating it is substantially equivalent to a predicate device.

  • What product code is assigned to the Valleylab Microwave Ablation Generator?

    The Valleylab Microwave Ablation Generator is assigned a product code of NEY and is classified as a class 2 device.