Soules Intrauterine Insemination Catheter
K-Number: K163318 · 2017-07-14
ApplicantCook Incorporated
Decision Date2017-07-14
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Soules Intrauterine Insemination Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-07-14 under approval number K163318. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Soules Intrauterine Insemination Catheter?
Soules Intrauterine Insemination Catheter is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Cook Incorporated. The 510(k) number is K163318.
When was Soules Intrauterine Insemination Catheter approved by the FDA?
Soules Intrauterine Insemination Catheter received FDA 510(k) clearance on 2017-07-14, under approval number K163318.
What company makes Soules Intrauterine Insemination Catheter?
Soules Intrauterine Insemination Catheter is manufactured by Cook Incorporated.
What is the FDA product code for Soules Intrauterine Insemination Catheter?
The FDA product code for Soules Intrauterine Insemination Catheter is MQF.
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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.