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FDA 510(k)

HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY

K-Number: K943494 · 1995-07-06

ApplicantLyco Enterprises, Inc.
Decision Date1995-07-06
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Lyco Enterprises, Inc.. It received FDA 510(k) clearance on 1995-07-06 under 510(k) number K943494. 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 HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY?

HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY is a medical device that received FDA 510(k) clearance on 1995-07-06. The listed applicant is Lyco Enterprises, Inc.. The 510(k) number is K943494.

When did HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY receive FDA 510(k) clearance?

HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY received FDA 510(k) clearance on 1995-07-06, under 510(k) number K943494.

Who is the listed applicant for HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY?

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

What is the FDA product code for HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY?

The FDA product code for HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Lyco Enterprises, 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.

K001115ULTRA CATHETER SET

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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