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FDA 510(k)

UTERINE INJECTOR

K-Number: K022503 · 2002-10-25

ApplicantThomas Medical, Inc.
Decision Date2002-10-25
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 Thomas Medical, Inc.. It received FDA 510(k) clearance on 2002-10-25 under 510(k) number K022503. 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 2002-10-25. The listed applicant is Thomas Medical, Inc.. The 510(k) number is K022503.

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

UTERINE INJECTOR received FDA 510(k) clearance on 2002-10-25, under 510(k) number K022503.

Who is the listed applicant for UTERINE INJECTOR?

The FDA 510(k) record lists Thomas Medical, 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.

Related Clinical Trials

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.

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Other records listing Thomas Medical, 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.

K022593THOMAS MEDICAL ELECTRODES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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