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FDA 510(k)

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter

K-Number: K181770 · 2019-03-29

ApplicantCook Incorporated
Decision Date2019-03-29
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-03-29 under approval number K181770. 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 Intrauterine Access Balloon Catheter, Selective Salpingography Catheter?

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Cook Incorporated. The 510(k) number is K181770.

When was Intrauterine Access Balloon Catheter, Selective Salpingography Catheter approved by the FDA?

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter received FDA 510(k) clearance on 2019-03-29, under approval number K181770.

What company makes Intrauterine Access Balloon Catheter, Selective Salpingography Catheter?

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Intrauterine Access Balloon Catheter, Selective Salpingography Catheter?

The FDA product code for Intrauterine Access Balloon Catheter, Selective Salpingography 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.

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