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FDA 510(k)

THE ADVANCE CATHETER FOR HSG AND SIS

K-Number: K123258 · 2013-01-31

ApplicantCatheter Research, Inc.
Decision Date2013-01-31
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THE ADVANCE CATHETER FOR HSG AND SIS is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Research, Inc.. It received FDA 510(k) clearance on 2013-01-31 under 510(k) number K123258. 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 THE ADVANCE CATHETER FOR HSG AND SIS?

THE ADVANCE CATHETER FOR HSG AND SIS is a medical device that received FDA 510(k) clearance on 2013-01-31. The listed applicant is Catheter Research, Inc.. The 510(k) number is K123258.

When did THE ADVANCE CATHETER FOR HSG AND SIS receive FDA 510(k) clearance?

THE ADVANCE CATHETER FOR HSG AND SIS received FDA 510(k) clearance on 2013-01-31, under 510(k) number K123258.

Who is the listed applicant for THE ADVANCE CATHETER FOR HSG AND SIS?

The FDA 510(k) record lists Catheter Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE ADVANCE CATHETER FOR HSG AND SIS?

The FDA product code for THE ADVANCE CATHETER FOR HSG AND SIS is LKF.

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Other records listing Catheter Research, Inc. as applicant

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.

K120154INTRAUTERINE INSEMINATION (IUI) CATHETERK032835H/S CATHETER SETK020292UTERINE INJECTORK973839DISPOSABLE ESOPHAGEAL STETHOSCOPEK974357UTERINE MANIPULATOR/INJECTORK951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING

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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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