Duna Ii Penile Prosthesis

• • Terminated Z-0702-2007 FDA Unclassified (pre-2012) ·initiated 19 Feb 2007

  Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.

• • Terminated Z-0703-2007 FDA Unclassified (pre-2012) ·initiated 19 Feb 2007

  Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.

510(k) Number

K953640 ↗

FDA Product Code

FAE

Device Class

Class II

Regulation

21 CFR Part 876.3630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Eska Jonas Silicone-Silver Penile Prost

  Class II

  FDA 510(k) K820081 Active Cleared 25 Jan 1982

• Dacomed Penile Prosthesis Sizer

  Class II

  FDA 510(k) K870320 Active Cleared 17 Mar 1987

• Forder Retractor

  Class I

  FDA 510(k) K811693 Active Cleared 26 Jun 1981

• Dacomed Snap-Gauge

  Unclassified

  FDA 510(k) K820615 Active Cleared 21 Apr 1982

• Dacomed External Male Continence Device

  Class I

  FDA 510(k) K885323 Active Cleared 8 Feb 1989

• Omni Phase Penile Prosthesis

  Class II

  FDA 510(k) K850019 Active Cleared 9 Apr 1985

See all devices from Dacomed Corp. →