uVue HSG/SHG Catheter
K-Number: K160217 · 2016-10-06
ApplicantCook Incorporated
Decision Date2016-10-06
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
uVue HSG/SHG Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-10-06 under approval number K160217. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uVue HSG/SHG Catheter?
uVue HSG/SHG Catheter is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Cook Incorporated. The 510(k) number is K160217.
When was uVue HSG/SHG Catheter approved by the FDA?
uVue HSG/SHG Catheter received FDA 510(k) clearance on 2016-10-06, under approval number K160217.
What company makes uVue HSG/SHG Catheter?
uVue HSG/SHG Catheter is manufactured by Cook Incorporated.
What is the FDA product code for uVue HSG/SHG Catheter?
The FDA product code for uVue HSG/SHG Catheter is LKF.
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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.