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510(k) K040959

MENTOR GENESIS PENILE PROSTHESIS by Mentor Corp. — Product Code FAE

K040959 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR GENESIS PENILE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 29, 2004. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. Mentor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2004
Date Received
April 13, 2004
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 Mentor Corp.

  • K130813 — MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TI (April 11, 2013)
  • K053414 — MENTOR NOVASILK MESH (December 27, 2005)
  • K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (June 3, 2005)
  • K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (November 9, 2004)
  • K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE (July 17, 2003)
  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K011500 — MENTOR CONTOUR PROFILE TISSUE EXPANDER (December 3, 2001)
  • K004005 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENES (October 12, 2001)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)

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)
  • K963328 — AMS AMBICOR PENILE PROSTHESIS (December 4, 1996)
  • K953640 — DUNA II PENILE PROSTHESIS (October 27, 1995)
  • 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)

FDA data resources