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FDA 510(k)

SE-100 VACUUM ERECTION DEVICE

K-Number: K012662 · 2001-11-09

ApplicantVts, Inc.
Decision Date2001-11-09
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SE-100 VACUUM ERECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Vts, Inc.. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012662. 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 SE-100 VACUUM ERECTION DEVICE?

SE-100 VACUUM ERECTION DEVICE is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Vts, Inc.. The 510(k) number is K012662.

When did SE-100 VACUUM ERECTION DEVICE receive FDA 510(k) clearance?

SE-100 VACUUM ERECTION DEVICE received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012662.

Who is the listed applicant for SE-100 VACUUM ERECTION DEVICE?

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

What is the FDA product code for SE-100 VACUUM ERECTION DEVICE?

The FDA product code for SE-100 VACUUM ERECTION 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 Vts, 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.

K012619VT-1K012639SE-300 VACUUM THERAPY SYSTEMK012620SE-200K992442V.T.S., INC. (V.T.-3)

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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