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FDA 510(k)

VARICOSCREEN(TM)

K-Number: K900404 · 1990-12-07

ApplicantPromedex, Inc.
Decision Date1990-12-07
Product CodeKYA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VARICOSCREEN(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Promedex, Inc.. It received FDA 510(k) clearance on 1990-12-07 under 510(k) number K900404. The device is classified under product code KYA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARICOSCREEN(TM)?

VARICOSCREEN(TM) is a medical device that received FDA 510(k) clearance on 1990-12-07. The listed applicant is Promedex, Inc.. The 510(k) number is K900404.

When did VARICOSCREEN(TM) receive FDA 510(k) clearance?

VARICOSCREEN(TM) received FDA 510(k) clearance on 1990-12-07, under 510(k) number K900404.

Who is the listed applicant for VARICOSCREEN(TM)?

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

What is the FDA product code for VARICOSCREEN(TM)?

The FDA product code for VARICOSCREEN(TM) is KYA.

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 Promedex, 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.

K914407PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)K905764SEMINOR

Related Devices (Code: KYA)

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.

K832989BREAST THERMAL ACTIVITY INDICATORBcsi Laboratories, Inc.K823245THERMAX; THERMAX SYSTEMAmerican Thermometer Company, Inc.K821524CHIROPRATIC INFRA-RED CRYSTAL PAKDr. John D. Reid B.A., D.C.K821049PARATHERMAmerican Thermometer Company, 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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