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LKY — Device, External Penile Rigidity Class II

FDA Device Classification

Classification Details

Product Code
LKY
Device Class
Class II
Regulation Number
876.5020
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K041573nanma mfg coNANMA VACUUM PUMP PROXZEK MODEL 2M9498SAugust 25, 2004
K032776vacurect manufacturing (pty)VACURECT VACUUM CONSTRICTION DEVICEOctober 3, 2003
K030119nanma mfg coNANMA ADJUSTABLE CONSTRICTION RINGAugust 6, 2003
K030913nanma mfg coNANMA VACUUM PUMPJune 3, 2003
K013113nanma mfg coMODIFICATION TO NANMA VACUUM PUMPDecember 20, 2002
K013051nanma mfg coNANMA ADJUSTABLE CONSTRICTION RINGAugust 22, 2002
K020969vacurect manufacturing (pty)VACURECT VACUUM CONSTRICTION DEVICEJune 5, 2002
K013053nanma mfg coMODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RINGMay 9, 2002
K020258pos-t-vacSUPPORT SLEEVEApril 4, 2002
K020154pos-t-vacVT-1April 4, 2002
K020082endocareERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSFebruary 5, 2002
K012662vtsSE-100 VACUUM ERECTION DEVICENovember 9, 2001
K012672pos-t-vacBOSS-2000-2 VACUUM ERECTION DEVICENovember 9, 2001
K012619vtsVT-1November 9, 2001
K012620vtsSE-200November 9, 2001
K012670pos-t-vacBOSS 2000-3 VACUUM ERECTION DEVICENovember 9, 2001
K012639vtsSE-300 VACUUM THERAPY SYSTEMNovember 9, 2001
K001859basic solutionsPENILE CONSTRICTOR RINGJanuary 11, 2001
K003115vivusACTIS ADJUSTABLE CONSTRICTION LOOPDecember 19, 2000
K000730impoaidIMPOAIDOctober 19, 2000