FDA 510(k)

PROSTATE BIOPSY NEEDLE

K-Number: K770122 · 1977-01-26

Decision Date1977-01-26

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PROSTATE BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1977-01-26 under 510(k) number K770122. 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 PROSTATE BIOPSY NEEDLE?

PROSTATE BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1977-01-26. The listed applicant is Cook, Inc.. The 510(k) number is K770122.

When did PROSTATE BIOPSY NEEDLE receive FDA 510(k) clearance?

PROSTATE BIOPSY NEEDLE received FDA 510(k) clearance on 1977-01-26, under 510(k) number K770122.

Who is the listed applicant for PROSTATE BIOPSY NEEDLE?

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

What is the FDA product code for PROSTATE BIOPSY NEEDLE?

The FDA product code for PROSTATE BIOPSY NEEDLE 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.