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FDA 510(k)

Disposable Pre-calibrated Brain Biopsy Needle 2.0

K-Number: K230201 · 2023-02-22

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2023-02-22
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable Pre-calibrated Brain Biopsy Needle 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K230201. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Pre-calibrated Brain Biopsy Needle 2.0?

Disposable Pre-calibrated Brain Biopsy Needle 2.0 is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K230201.

When did Disposable Pre-calibrated Brain Biopsy Needle 2.0 receive FDA 510(k) clearance?

Disposable Pre-calibrated Brain Biopsy Needle 2.0 received FDA 510(k) clearance on 2023-02-22, under 510(k) number K230201.

Who is the listed applicant for Disposable Pre-calibrated Brain Biopsy Needle 2.0?

The FDA 510(k) record lists PAJUNK GmbH Medizintechnologie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Pre-calibrated Brain Biopsy Needle 2.0?

The FDA product code for Disposable Pre-calibrated Brain Biopsy Needle 2.0 is HAW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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