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.

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United States Code

Title 21 published on 19-May-2018 03:57

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

  • 2017-11-14; vol. 82 # 218 - Tuesday, November 14, 2017
    1. 82 FR 52649 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostatic Artery Embolization Device
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective November 14, 2017. The classification was applicable on June 21, 2017.
      21 CFR Part 876