Title 21: Food and Drugs
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/ PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
/ Subpart F - Therapeutic Devices / § 876.5160 Urological clamp.
§ 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.