21 CFR 876.5160 - Urological clamp for males.

§ 876.5160 Urological clamp for males.

(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 or use on females, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

[ 48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000]

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 876 after this date.

  • 2017-03-01; vol. 82 # 39 - Wednesday, March 1, 2017
    1. 82 FR 12171 - Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective March 1, 2017.
      21 CFR Part 876