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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-10-26 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K180291.

When did Cook Silicone Balloon HSG Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Cook Silicone Balloon HSG Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, Inc.

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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