Home / 510(k) Clearances / K983015

510(k) K983015

VIRILIS PENILE PROSTHESIS by Specialty Surgical Products, Inc. — Product Code FTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1999
Date Received
August 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Penis, Rigid Rod
Device Class
Class II
Regulation Number
876.3630
Review Panel
GU
Submission Type

Other clearances by Specialty Surgical Products, Inc.

  • K140383 — ALLOX2 TISSUE EXPANDERS (October 28, 2014)
  • K070303 — SILICONE TISSUE EXPANDER (June 22, 2007)
  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
  • K982258 — MAMMARY SIZER (September 8, 1998)
  • K982065 — STERILE SILICONE EXTERNAL WOUND COVER (August 12, 1998)
  • K982067 — MAGNETIC PORT SILICONE TISSUE EXPANDER (July 13, 1998)
  • K974653 — SILICONE ELASTOMER SHEETING (March 13, 1998)
  • K974654 — SILICONE BLOCKS (February 24, 1998)
  • K974209 — SILICONE TISSUE/INFLATABLE TISSUE EXPANDER (February 6, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)

Other clearances for product code FTQ

  • K830667 — SILICONE-SILVER PENILE PROSTHESIS-ESK (October 20, 1983)