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Modification to Neothermia's En-bloc Biopsy System

by Neothermia Corp.

510(k) K023413

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 NumberK023413 Date8 Nov 2002ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 en-bloc Biopsy System is a percutaneous, high-frequency, automated, vacuum-assisted electrosurgical device intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It removes tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume.

The system consists of a hand-held biopsy handle with an integral cable connecting to a control unit. The en-bloc Biopsy Probe is a single-use component available in 10mm, 12mm, 15mm, and 20mm sizes. The device is supplied sterile and is regulated under FDA 510(k) clearance.

Other devices from Neothermia Corp.

See all devices from Neothermia Corp. →

Questions

AI-generated answers, 27 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 Neothermia En-Bloc Biopsy System used for?

    The system is a percutaneous, high-frequency, automated, vacuum-assisted electrosurgical device intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It removes tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume.

  • How is the device supplied and is it sterile?

    The en-bloc Biopsy Probe is a single-use component that is supplied sterile. The system consists of a hand-held biopsy handle with an integral cable connecting to a control unit.

  • What sizes are available for the biopsy probe?

    The en-bloc Biopsy Probe is available in four sizes: 10mm, 12mm, 15mm, and 20mm.

  • What is the regulatory status of this device?

    The device is regulated under FDA 510(k) clearance. It was found to be substantially equivalent to a predicate device and cleared by the FDA on November 8, 2002.