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FDA 510(k)

COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING

K-Number: K880100 · 1988-03-15

ApplicantCook Urological, Inc.
Decision Date1988-03-15
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING 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 1988-03-15 under 510(k) number K880100. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING?

COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Cook Urological, Inc.. The 510(k) number is K880100.

When did COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING receive FDA 510(k) clearance?

COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880100.

Who is the listed applicant for COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING?

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 UROLOGICAL WIRE GUIDE W/HYDROMER COATING?

The FDA product code for COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING is KOD.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: KOD)

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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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