FDA 510(k)

SENORX BIOPSY DEVICE II

K-Number: K040842 · 2004-04-30

Decision Date2004-04-30

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SENORX BIOPSY DEVICE II is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2004-04-30 under 510(k) number K040842. 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 SENORX BIOPSY DEVICE II?

SENORX BIOPSY DEVICE II is a medical device that received FDA 510(k) clearance on 2004-04-30. The listed applicant is Senorx, Inc.. The 510(k) number is K040842.

When did SENORX BIOPSY DEVICE II receive FDA 510(k) clearance?

SENORX BIOPSY DEVICE II received FDA 510(k) clearance on 2004-04-30, under 510(k) number K040842.

Who is the listed applicant for SENORX BIOPSY DEVICE II?

The FDA 510(k) record lists Senorx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENORX BIOPSY DEVICE II?

The FDA product code for SENORX BIOPSY DEVICE II is KNW.

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Related Devices (Code: 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.