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510(k) K830917

SURGITEK SIZER FOR PENILE PROSTHESIS by Medical Engineering Corp. — Product Code FAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
March 22, 1983
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 Medical Engineering Corp.

  • K934141 — STAND ALONE CYSTOMETROGRAM (November 18, 1993)
  • K905289 — SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT (March 13, 1991)
  • K903448 — SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER (January 14, 1991)
  • K902773 — SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET (July 16, 1990)
  • K884746 — SURGITEK FLAT T-SPAN (August 10, 1989)
  • K883274 — SURGITEK (R) UROFLOW SYSTEM (February 8, 1989)
  • K881736 — SURGITEK CO2 DELIVERY SYSTEM (August 11, 1988)
  • K880801 — SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 (May 26, 1988)
  • K880802 — SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 (May 26, 1988)
  • K842748 — SURGITEK RECONSTRUC-NIPPLE PROSTHESIS (September 26, 1984)

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)