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Concerto Bipolar Needle Electrode

by Boston Scientific 2 variants

510(k) K040785

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 · Special NumberK040785 Date28 Apr 2004ClearedStatusActive

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  • Withdrawn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
GEI
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Concerto Bipolar Needle Electrode is an electrosurgical device designed for use with a Boston Scientific radiofrequency generator to achieve thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. It is classified under the GEI product code as an electrosurgical cutting and coagulation device accessory.

The device is supplied as a single-use, sterile accessory intended for use in clinical settings such as general and plastic surgery procedures. It requires connection to a compatible RF generator and is regulated as a Class II medical device under FDA 510(k) clearance, with special controls applying to its GEI classification.

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Questions

AI-generated answers, 6 Oct 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 Concerto Bipolar Needle Electrode used for?

    The Concerto Bipolar Needle Electrode is designed to achieve thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions, when used with a Boston Scientific radiofrequency generator.

  • Is the Concerto Bipolar Needle Electrode sterile and single-use?

    Yes, the device is supplied as a single-use, sterile accessory intended for use in clinical settings such as general and plastic surgery procedures, ensuring infection control and eliminating the need for reprocessing.

  • What equipment is required to operate the Concerto Bipolar Needle Electrode?

    The Concerto Bipolar Needle Electrode requires connection to a compatible Boston Scientific radiofrequency generator to function, as it is designed specifically for use with their RF generator system to deliver electrosurgical energy.

  • How is the Concerto Bipolar Needle Electrode classified and cleared?

    The device is classified under the GEI product code as an electrosurgical cutting and coagulation device accessory and is regulated as a Class II medical device under FDA 510(k) clearance, with special controls applying to its GEI classification.