Home / 510(k) Clearances / K953640

510(k) K953640

DUNA II PENILE PROSTHESIS by Dacomed Corp. — Product Code FAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1995
Date Received
August 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Penile
Device Class
Class II
Regulation Number
876.3630
Review Panel
GU
Submission Type

Other clearances by Dacomed Corp.

  • K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (August 25, 1994)
  • K920409 — DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE (May 11, 1992)
  • K920420 — DURA II PENILE PROSTHESIS (April 16, 1992)
  • K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS (October 11, 1991)
  • K900774 — DACOMED NEGATIVE PRESSURE ERECTION DEVICE (May 4, 1990)
  • K885323 — DACOMED EXTERNAL MALE CONTINENCE DEVICE (February 8, 1989)
  • K880391 — DACOMED CYSTOMETER (April 27, 1988)
  • K871653 — DURAPHASE PENILE PROSTHESIS (September 18, 1987)
  • K870320 — DACOMED PENILE PROSTHESIS SIZER (March 17, 1987)
  • K854118 — DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS (March 17, 1986)

Other clearances for product code FAE

  • K183619 — Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, (April 16, 2019)
  • K181673 — Rigi10 Malleable Penile Prosthesis (April 15, 2019)
  • K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (April 9, 2009)
  • K082006 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (October 20, 2008)
  • K040959 — MENTOR GENESIS PENILE PROSTHESIS (October 29, 2004)
  • K963328 — AMS AMBICOR PENILE PROSTHESIS (December 4, 1996)
  • K951716 — AMS 650 MALLERABLE PENIEL PROSTHESIS (July 6, 1995)
  • K920420 — DURA II PENILE PROSTHESIS (April 16, 1992)
  • K912935 — AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS (March 18, 1992)
  • K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS (October 11, 1991)