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FDA 510(k)

ACTIS ADJUSTABLE CONSTRICTION LOOP

K-Number: K003115 · 2000-12-19

ApplicantVivus, Inc.
Decision Date2000-12-19
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACTIS ADJUSTABLE CONSTRICTION LOOP is the device name listed in this FDA 510(k) record. The listed applicant is Vivus, Inc.. It received FDA 510(k) clearance on 2000-12-19 under 510(k) number K003115. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIS ADJUSTABLE CONSTRICTION LOOP?

ACTIS ADJUSTABLE CONSTRICTION LOOP is a medical device that received FDA 510(k) clearance on 2000-12-19. The listed applicant is Vivus, Inc.. The 510(k) number is K003115.

When did ACTIS ADJUSTABLE CONSTRICTION LOOP receive FDA 510(k) clearance?

ACTIS ADJUSTABLE CONSTRICTION LOOP received FDA 510(k) clearance on 2000-12-19, under 510(k) number K003115.

Who is the listed applicant for ACTIS ADJUSTABLE CONSTRICTION LOOP?

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

What is the FDA product code for ACTIS ADJUSTABLE CONSTRICTION LOOP?

The FDA product code for ACTIS ADJUSTABLE CONSTRICTION LOOP is LKY.

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 Vivus, 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.

K962915ACTIS (VENOUS FLOW CONTROLLER)

Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.

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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