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510(k) K910214

AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS by American Medical Corp. — Product Code FAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1991
Date Received
January 17, 1991
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 American Medical Corp.

  • K922493 — AMERICAN MEDICAL MFG. LUMBAR CPM (July 27, 1992)
  • K915067 — DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS (March 11, 1992)

Other clearances for product code FAE

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  • 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)