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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 the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2022-08-17 under 510(k) 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. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K220897.

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

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

Who is the listed applicant for Disposable 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 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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