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FDA 510(k)

Cook Silicone Balloon HSG Catheter

K-Number: K180291 · 2018-10-26

ApplicantCook Incorporated
Decision Date2018-10-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cook Silicone Balloon HSG Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-10-26 under approval number K180291. 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 Cook Silicone Balloon HSG Catheter?

Cook Silicone Balloon HSG Catheter is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Cook Incorporated. The 510(k) number is K180291.

When was Cook Silicone Balloon HSG Catheter approved by the FDA?

Cook Silicone Balloon HSG Catheter received FDA 510(k) clearance on 2018-10-26, under approval number K180291.

What company makes Cook Silicone Balloon HSG Catheter?

Cook Silicone Balloon HSG Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Cook Silicone Balloon HSG Catheter?

The FDA product code for Cook Silicone Balloon HSG Catheter is LKF.

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Related Devices (Code: 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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