FDA 510(k)

BIOPSY HANDY, MRI BIOPSY HANDY

K-Number: K102771 · 2011-06-24

ApplicantSomatex Medical Technologies GmbH

Decision Date2011-06-24

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BIOPSY HANDY, MRI BIOPSY HANDY is the device name listed in this FDA 510(k) record. The listed applicant is Somatex Medical Technologies GmbH. It received FDA 510(k) clearance on 2011-06-24 under 510(k) number K102771. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY HANDY, MRI BIOPSY HANDY?

BIOPSY HANDY, MRI BIOPSY HANDY is a medical device that received FDA 510(k) clearance on 2011-06-24. The listed applicant is Somatex Medical Technologies GmbH. The 510(k) number is K102771.

When did BIOPSY HANDY, MRI BIOPSY HANDY receive FDA 510(k) clearance?

BIOPSY HANDY, MRI BIOPSY HANDY received FDA 510(k) clearance on 2011-06-24, under 510(k) number K102771.

Who is the listed applicant for BIOPSY HANDY, MRI BIOPSY HANDY?

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

What is the FDA product code for BIOPSY HANDY, MRI BIOPSY HANDY?

The FDA product code for BIOPSY HANDY, MRI BIOPSY HANDY is KNW.

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Official Source

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