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510(k) K181673

Rigi10 Malleable Penile Prosthesis by Rigicon, Inc. — Product Code FAE

K181673 is an FDA 510(k) premarket notification submitted by Rigicon, Inc. for the device "Rigi10 Malleable Penile Prosthesis". The FDA issued a decision of Substantially Equivalent on April 15, 2019. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2019
Date Received
June 25, 2018
Clearance Type
Abbreviated
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 for product code FAE

  • K183619 — Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, (April 16, 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)
  • K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS (October 11, 1991)

FDA data resources