FDA 510(k)

MEADOX(R) SURGIMED(R) BIOPSY GUN II

K-Number: K911635 · 1991-06-20

Decision Date1991-06-20

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MEADOX(R) SURGIMED(R) BIOPSY GUN II is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Surgimed, Inc.. It received FDA 510(k) clearance on 1991-06-20 under 510(k) number K911635. 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 MEADOX(R) SURGIMED(R) BIOPSY GUN II?

MEADOX(R) SURGIMED(R) BIOPSY GUN II is a medical device that received FDA 510(k) clearance on 1991-06-20. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K911635.

When did MEADOX(R) SURGIMED(R) BIOPSY GUN II receive FDA 510(k) clearance?

MEADOX(R) SURGIMED(R) BIOPSY GUN II received FDA 510(k) clearance on 1991-06-20, under 510(k) number K911635.

Who is the listed applicant for MEADOX(R) SURGIMED(R) BIOPSY GUN II?

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

What is the FDA product code for MEADOX(R) SURGIMED(R) BIOPSY GUN II?

The FDA product code for MEADOX(R) SURGIMED(R) BIOPSY GUN II 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.