K Number
K010365Device Name
ORTHO CONTROL FEMALE URINARY CONTROL DEVICEManufacturer
Date Cleared
2001-04-30
(82 days)
Product Code
Regulation Number
876.5160Type
TraditionalPanel
GUReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 876.5160 Urological clamp.
(a)
Identification. A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.(b)
Classification. Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.