FDA 510(k)

MAMMOTOME EX HAND HELD SYSTEM

K-Number: K033700 · 2004-02-20

Decision Date2004-02-20

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MAMMOTOME EX HAND HELD 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 2004-02-20 under 510(k) number K033700. 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 EX HAND HELD SYSTEM?

MAMMOTOME EX HAND HELD SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K033700.

When did MAMMOTOME EX HAND HELD SYSTEM receive FDA 510(k) clearance?

MAMMOTOME EX HAND HELD SYSTEM received FDA 510(k) clearance on 2004-02-20, under 510(k) number K033700.

Who is the listed applicant for MAMMOTOME EX HAND HELD 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 EX HAND HELD SYSTEM?

The FDA product code for MAMMOTOME EX HAND HELD SYSTEM is KNW.

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Official Source

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