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FDA 510(k)

Disposable Brain Biopsy Needle 2.0

K-Number: K220897 · 2022-08-17

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2022-08-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable Brain Biopsy Needle 2.0 is a medical device manufactured by PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2022-08-17 under approval number K220897. 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 Brain Biopsy Needle 2.0?

Disposable Brain Biopsy Needle 2.0 is a medical device that received FDA 510(k) clearance on 2022-08-17. It is manufactured by PAJUNK GmbH Medizintechnologie. The 510(k) number is K220897.

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

Disposable Brain Biopsy Needle 2.0 received FDA 510(k) clearance on 2022-08-17, under approval number K220897.

What company makes Disposable Brain Biopsy Needle 2.0?

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

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

The FDA product code for Disposable 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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