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FDA 510(k)

PENILE CONSTRICTOR RING

K-Number: K001859 · 2001-01-11

ApplicantBasic Solutions, LLC
Decision Date2001-01-11
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENILE CONSTRICTOR RING is the device name listed in this FDA 510(k) record. The listed applicant is Basic Solutions, LLC. It received FDA 510(k) clearance on 2001-01-11 under 510(k) number K001859. 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 PENILE CONSTRICTOR RING?

PENILE CONSTRICTOR RING is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Basic Solutions, LLC. The 510(k) number is K001859.

When did PENILE CONSTRICTOR RING receive FDA 510(k) clearance?

PENILE CONSTRICTOR RING received FDA 510(k) clearance on 2001-01-11, under 510(k) number K001859.

Who is the listed applicant for PENILE CONSTRICTOR RING?

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

What is the FDA product code for PENILE CONSTRICTOR RING?

The FDA product code for PENILE CONSTRICTOR RING is LKY.

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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

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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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