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FDA 510(k)

UTERINE INJECTOR

K-Number: K020292 · 2002-04-17

ApplicantCatheter Research, Inc.
Decision Date2002-04-17
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTERINE 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 2002-04-17 under 510(k) number K020292. 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 INJECTOR?

UTERINE INJECTOR is a medical device that received FDA 510(k) clearance on 2002-04-17. The listed applicant is Catheter Research, Inc.. The 510(k) number is K020292.

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

UTERINE INJECTOR received FDA 510(k) clearance on 2002-04-17, under 510(k) number K020292.

Who is the listed applicant for UTERINE 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 INJECTOR?

The FDA product code for UTERINE 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 SETK973839DISPOSABLE 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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