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FDA 510(k)

Williams Cystoscopic Injection Needle

K-Number: K171602 · 2017-07-28

ApplicantCook Incorporated
Decision Date2017-07-28
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Williams Cystoscopic Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K171602. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Williams Cystoscopic Injection Needle?

Williams Cystoscopic Injection Needle is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Cook Incorporated. The 510(k) number is K171602.

When did Williams Cystoscopic Injection Needle receive FDA 510(k) clearance?

Williams Cystoscopic Injection Needle received FDA 510(k) clearance on 2017-07-28, under 510(k) number K171602.

Who is the listed applicant for Williams Cystoscopic Injection Needle?

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

What is the FDA product code for Williams Cystoscopic Injection Needle?

The FDA product code for Williams Cystoscopic Injection Needle is FBK.

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Related Devices (Code: FBK)

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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