21 CFR 876.3630 - Penile rigidity implant.

§ 876.3630 Penile rigidity implant.

(a)Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

(b)Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”

[ 65 FR 4882, Feb. 2, 2000]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 2015-12-03

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