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Daum-lectric MRI Drilling Machine

by Mri Devices Daum GmbH

510(k) K021098

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 NumberK021098 Date3 Dec 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  • Withdrawn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
ERL
Device Class
Class II
Regulation
21 CFR Part 874.4250
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Daum-lectric MRI Drilling Machine is a surgical drill, electric or pneumatic, including handpiece, intended for use in ear, nose, and throat procedures. It is designed to drill into hard and soft bone tissue to create a small hole or obtain bony tissue samples.

This device is supplied as a reusable instrument and has received FDA 510(k) clearance under K021098. It is classified as a Class II medical device under regulation number 874.4250 and product code ERL, with authorization based on substantial equivalence to a predicate device.

Questions

AI-generated answers, 25 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 Daum-lectric MRI Drilling Machine used for?

    It is intended for use in ear, nose, and throat procedures to drill into hard and soft bone tissue to create a small hole or obtain bony tissue samples, as stated in the device description.

  • Is the Daum-lectric MRI Drilling Machine reusable or single-use?

    The device is supplied as a reusable instrument, meaning it can be cleaned, sterilized, and used multiple times following appropriate reprocessing procedures.

  • What power options does the Daum-lectric MRI Drilling Machine support?

    The device is available as either an electric or pneumatic surgical drill, including the handpiece, allowing flexibility in clinical settings based on available infrastructure.

  • What regulatory pathway was used for the Daum-lectric MRI Drilling Machine?

    It received FDA 510(k) clearance under K021098, based on substantial equivalence to a predicate device, and is classified as a Class II medical device under regulation 874.4250.

  • What is the product code for the Daum-lectric MRI Drilling Machine?

    The device is assigned product code ERL, which identifies it as a Drill, Surgical, ENT (Electric Or Pneumatic) Including Handpiece within the FDA’s product classification system.