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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 a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2023-02-22 under approval 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. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K230201.

When was Disposable Pre-calibrated Brain Biopsy Needle 2.0 approved by the FDA?

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

What company makes Disposable Pre-calibrated Brain Biopsy Needle 2.0?

Disposable Pre-calibrated Brain Biopsy Needle 2.0 is manufactured by PAJUNK GmbH Medizintechnologie.

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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