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FDA 510(k)

BRAIN BIOPSY NEEDLE

K-Number: K112094 · 2012-04-24

ApplicantAd-Tech Medical Instrument Corp
Decision Date2012-04-24
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAIN BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corp. It received FDA 510(k) clearance on 2012-04-24 under 510(k) number K112094. 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 BRAIN BIOPSY NEEDLE?

BRAIN BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 2012-04-24. The listed applicant is Ad-Tech Medical Instrument Corp. The 510(k) number is K112094.

When did BRAIN BIOPSY NEEDLE receive FDA 510(k) clearance?

BRAIN BIOPSY NEEDLE received FDA 510(k) clearance on 2012-04-24, under 510(k) number K112094.

Who is the listed applicant for BRAIN BIOPSY NEEDLE?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAIN BIOPSY NEEDLE?

The FDA product code for BRAIN BIOPSY NEEDLE is HAW.

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Other records listing Ad-Tech Medical Instrument Corp as applicant

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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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