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FDA 510(k)

COOK INSEMINATION CUP

K-Number: K950714 · 1995-05-11

ApplicantCook Urological, Inc.
Decision Date1995-05-11
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COOK INSEMINATION CUP is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K950714. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK INSEMINATION CUP?

COOK INSEMINATION CUP is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Cook Urological, Inc.. The 510(k) number is K950714.

When did COOK INSEMINATION CUP receive FDA 510(k) clearance?

COOK INSEMINATION CUP received FDA 510(k) clearance on 1995-05-11, under 510(k) number K950714.

Who is the listed applicant for COOK INSEMINATION CUP?

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

What is the FDA product code for COOK INSEMINATION CUP?

The FDA product code for COOK INSEMINATION CUP is HDR.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: HDR)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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