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FDA 510(k)

THE INQUINAL RESORVOIR INSERTER

K-Number: K802983 · 1980-12-30

ApplicantLone Star Medical Products, Inc.
Decision Date1980-12-30
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE INQUINAL RESORVOIR INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Lone Star Medical Products, Inc.. It received FDA 510(k) clearance on 1980-12-30 under 510(k) number K802983. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE INQUINAL RESORVOIR INSERTER?

THE INQUINAL RESORVOIR INSERTER is a medical device that received FDA 510(k) clearance on 1980-12-30. The listed applicant is Lone Star Medical Products, Inc.. The 510(k) number is K802983.

When did THE INQUINAL RESORVOIR INSERTER receive FDA 510(k) clearance?

THE INQUINAL RESORVOIR INSERTER received FDA 510(k) clearance on 1980-12-30, under 510(k) number K802983.

Who is the listed applicant for THE INQUINAL RESORVOIR INSERTER?

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

What is the FDA product code for THE INQUINAL RESORVOIR INSERTER?

The FDA product code for THE INQUINAL RESORVOIR INSERTER is KOA.

Related Clinical Trials

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Other records listing Lone Star Medical Products, 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.

K850041P-3 CLOSING INSTRUMENTK831531SURGICAL ISOLATION BARRIER SYSTEMK820015URETHAL CUTTER CLAMPK810915THE SCOTT DIALMENZENSERTK791665SCOTTS SURGICAL RETRACTOR AND ELASTIC

Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K931181VESITEC SUTURE PASSERVesitec Medical, Inc.K921304DDV LIGATORNorth American Medical, 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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