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FDA 510(k)

SOFTSEAL HSG CATHETER

K-Number: K040238 · 2004-06-22

ApplicantModern Medical Equipment Mfg., Ltd.
Decision Date2004-06-22
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOFTSEAL HSG CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Mfg., Ltd.. It received FDA 510(k) clearance on 2004-06-22 under 510(k) number K040238. 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 SOFTSEAL HSG CATHETER?

SOFTSEAL HSG CATHETER is a medical device that received FDA 510(k) clearance on 2004-06-22. The listed applicant is Modern Medical Equipment Mfg., Ltd.. The 510(k) number is K040238.

When did SOFTSEAL HSG CATHETER receive FDA 510(k) clearance?

SOFTSEAL HSG CATHETER received FDA 510(k) clearance on 2004-06-22, under 510(k) number K040238.

Who is the listed applicant for SOFTSEAL HSG CATHETER?

The FDA 510(k) record lists Modern Medical Equipment Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTSEAL HSG CATHETER?

The FDA product code for SOFTSEAL HSG CATHETER is LKF.

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Other records listing Modern Medical Equipment Mfg., Ltd. as applicant

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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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