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FDA 510(k)

COOK SIDEARM CORE TISSUE BIOPSY DEVICE

K-Number: K041544 · 2004-07-22

ApplicantUrological, Inc.
Decision Date2004-07-22
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK SIDEARM CORE TISSUE BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Urological, Inc.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K041544. 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 COOK SIDEARM CORE TISSUE BIOPSY DEVICE?

COOK SIDEARM CORE TISSUE BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is Urological, Inc.. The 510(k) number is K041544.

When did COOK SIDEARM CORE TISSUE BIOPSY DEVICE receive FDA 510(k) clearance?

COOK SIDEARM CORE TISSUE BIOPSY DEVICE received FDA 510(k) clearance on 2004-07-22, under 510(k) number K041544.

Who is the listed applicant for COOK SIDEARM CORE TISSUE BIOPSY DEVICE?

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

What is the FDA product code for COOK SIDEARM CORE TISSUE BIOPSY DEVICE?

The FDA product code for COOK SIDEARM CORE TISSUE BIOPSY DEVICE is KNW.

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Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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