FDA 510(k)

MAMMOTOME MR BIOPSY SYSTEM

K-Number: K042753 · 2004-11-08

Decision Date2004-11-08

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MAMMOTOME MR BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 2004-11-08 under 510(k) number K042753. 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 MAMMOTOME MR BIOPSY SYSTEM?

MAMMOTOME MR BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-08. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K042753.

When did MAMMOTOME MR BIOPSY SYSTEM receive FDA 510(k) clearance?

MAMMOTOME MR BIOPSY SYSTEM received FDA 510(k) clearance on 2004-11-08, under 510(k) number K042753.

Who is the listed applicant for MAMMOTOME MR BIOPSY SYSTEM?

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

What is the FDA product code for MAMMOTOME MR BIOPSY SYSTEM?

The FDA product code for MAMMOTOME MR BIOPSY SYSTEM is KNW.

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Other records listing Ethicon Endo-Surgery, Inc. as applicant

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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.