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510(k) K860517

MENTOR CORPORAL DILATORS by Mentor Corp. — Product Code FAE

K860517 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR CORPORAL DILATORS". The FDA issued a decision of Substantially Equivalent on March 11, 1986. 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
March 11, 1986
Date Received
February 11, 1986
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)
  • K040959 — MENTOR GENESIS PENILE PROSTHESIS (October 29, 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)

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)
  • 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)

FDA data resources