Skip to content

Brainpro, Brainpro Access

by Pajunk GmbH Medizintechnologie

510(k) K060808

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 NumberK060808 Date25 Jul 2006ClearedStatusActive

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  • Withdrawn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
HAW
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
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 Brainpro and Brainpro Access are anchoring and guidance instruments designed for use with the Brainpro biopsy cannula. These devices facilitate the collection of brain tissue samples through drill holes using a cutting titanium thread.

This device is supplied as a single-use instrument. It has received FDA 510(k) clearance under K060808.

Other devices from Pajunk GmbH Medizintechnologie

See all devices from Pajunk GmbH Medizintechnologie →

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 primary function of the Brainpro and Brainpro Access instruments?

    These instruments are designed to serve as anchoring and guidance tools for the Brainpro biopsy cannula. They facilitate the collection of brain tissue samples through drill holes by utilizing a specialized cutting titanium thread.

  • Are these instruments intended for single-use or can they be reprocessed?

    The Brainpro and Brainpro Access are supplied as single-use instruments. This design ensures that each procedure is performed with a sterile, unused device, eliminating the need for cleaning or sterilization between patients.

  • What is the regulatory status of the Brainpro system?

    The Brainpro and Brainpro Access have received FDA 510(k) clearance under K060808. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.