Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VACURECT VACUUM CONSTRICTION DEVICE

K-Number: K020969 · 2002-06-05

ApplicantVacurect Manufacturing (Pty) , Ltd.
Decision Date2002-06-05
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VACURECT VACUUM CONSTRICTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Vacurect Manufacturing (Pty) , Ltd.. It received FDA 510(k) clearance on 2002-06-05 under 510(k) number K020969. 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 VACURECT VACUUM CONSTRICTION DEVICE?

VACURECT VACUUM CONSTRICTION DEVICE is a medical device that received FDA 510(k) clearance on 2002-06-05. The listed applicant is Vacurect Manufacturing (Pty) , Ltd.. The 510(k) number is K020969.

When did VACURECT VACUUM CONSTRICTION DEVICE receive FDA 510(k) clearance?

VACURECT VACUUM CONSTRICTION DEVICE received FDA 510(k) clearance on 2002-06-05, under 510(k) number K020969.

Who is the listed applicant for VACURECT VACUUM CONSTRICTION DEVICE?

The FDA 510(k) record lists Vacurect Manufacturing (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACURECT VACUUM CONSTRICTION DEVICE?

The FDA product code for VACURECT VACUUM CONSTRICTION DEVICE 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 Vacurect Manufacturing (Pty) , Ltd. 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.

K032776VACURECT VACUUM CONSTRICTION DEVICE

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.

↑