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FDA 510(k)

INSULATOR WIRE GUIDE

K-Number: K972977 · 1997-10-10

ApplicantCook Urological, Inc.
Decision Date1997-10-10
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSULATOR WIRE GUIDE 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 1997-10-10 under 510(k) number K972977. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSULATOR WIRE GUIDE?

INSULATOR WIRE GUIDE is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Cook Urological, Inc.. The 510(k) number is K972977.

When did INSULATOR WIRE GUIDE receive FDA 510(k) clearance?

INSULATOR WIRE GUIDE received FDA 510(k) clearance on 1997-10-10, under 510(k) number K972977.

Who is the listed applicant for INSULATOR WIRE GUIDE?

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 INSULATOR WIRE GUIDE?

The FDA product code for INSULATOR WIRE GUIDE is KNY.

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Other records listing Cook Urological, Inc. as applicant

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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Related Devices (Code: KNY)

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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