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FDA 510(k)

UTERINE MANIPULATOR/INJECTOR

K-Number: K974357 · 1998-02-02

ApplicantCatheter Research, Inc.
Decision Date1998-02-02
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTERINE MANIPULATOR/INJECTOR 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 1998-02-02 under 510(k) number K974357. 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 UTERINE MANIPULATOR/INJECTOR?

UTERINE MANIPULATOR/INJECTOR is a medical device that received FDA 510(k) clearance on 1998-02-02. The listed applicant is Catheter Research, Inc.. The 510(k) number is K974357.

When did UTERINE MANIPULATOR/INJECTOR receive FDA 510(k) clearance?

UTERINE MANIPULATOR/INJECTOR received FDA 510(k) clearance on 1998-02-02, under 510(k) number K974357.

Who is the listed applicant for UTERINE MANIPULATOR/INJECTOR?

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 UTERINE MANIPULATOR/INJECTOR?

The FDA product code for UTERINE MANIPULATOR/INJECTOR 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.

K123258THE ADVANCE CATHETER FOR HSG AND SISK120154INTRAUTERINE INSEMINATION (IUI) CATHETERK032835H/S CATHETER SETK020292UTERINE INJECTORK973839DISPOSABLE ESOPHAGEAL STETHOSCOPEK951345DISPOSABLE 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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