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 a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-07-28 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K171602.
When was Williams Cystoscopic Injection Needle approved by the FDA?
Williams Cystoscopic Injection Needle received FDA 510(k) clearance on 2017-07-28, under approval number K171602.
What company makes Williams Cystoscopic Injection Needle?
Williams Cystoscopic Injection Needle is manufactured by Cook Incorporated.
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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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.