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Soloist Single Needle Electrodeelectrode

by Boston Scientific

510(k) K053128

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK053128 Date30 Nov 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1319-2012 FDA Not yet classified initiated 2 Mar 2012

    Device found labeled with the incorrect expiration dates. The Soloist Single Needle Electrode has been qualified for a 3 year expiration date. Product manufactured between the dates of May 24, 2011 and November 8, 2011 has an incorrect expiration date of 20 years labeled on the pouched needle electrode and 5 years labeled on the carton.

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  • Withdrawn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, 24 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 Soloist Single Needle Electrode is an electrosurgical device designed for cutting and coagulation. It features a trocar tip for accessing small or difficult-to-treat lesions and includes 1 cm shaft markings to assist with needle placement accuracy.

This disposable, monopolar device consists of an electrode tip, an insulated delivery needle with a handle, and a cable. It is intended for use in conjunction with a Boston Scientific radiofrequency generator and may be used with the Coaccess Introducer. The device is subject to FDA 510(k) clearance.

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Questions

AI-generated answers, 24 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 primary clinical application for the Soloist Single Needle Electrode?

    This device is designed for electrosurgical cutting and coagulation. Its trocar tip is specifically engineered to facilitate access to small or difficult-to-treat lesions during procedures.

  • Is the Soloist Single Needle Electrode intended for multiple uses?

    No, this is a disposable device. It is designed for single-patient use to ensure sterility and prevent cross-contamination between procedures.

  • What equipment is required to operate this electrode?

    The Soloist Single Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency generator. It is also compatible for use with the Coaccess Introducer to assist in the procedure.

  • How does the device assist with needle placement accuracy?

    The device features 1 cm shaft markings along the insulated delivery needle. These markings provide a visual reference for the clinician to assist with accurate needle placement during the procedure.