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510(k) K912934

AMS SPHINCTER 800 URINARY PROSTHESIS by American Medical Systems, Inc. — Product Code FAG

K912934 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "AMS SPHINCTER 800 URINARY PROSTHESIS". The FDA issued a decision of Substantially Equivalent on March 18, 1992. The device falls under product code FAG (Prosthesis, Urethral Sphincter), a Class III device. American Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
July 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Urethral Sphincter
Device Class
Class III
Regulation Number
Review Panel
GU
Submission Type

Other clearances by American Medical Systems, Inc.

  • K140679 — SUREFLEX LITHOTRIPSY LASER FIBERS (June 20, 2014)
  • K131229 — SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS (December 5, 2013)
  • K132655 — RETROARC RETROPUBIC SLING SYSTEM (November 20, 2013)
  • K121805 — AMS LARGE PORE POLYPROPHLENE MESH (October 16, 2012)
  • K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEM (September 7, 2012)
  • K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (July 20, 2012)
  • K120870 — GREENLIGHT MOXY FIBER OPTIC (June 15, 2012)
  • K112842 — AMS ELEVATE PC (October 25, 2011)
  • K111118 — AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR S (July 1, 2011)
  • K100746 — FIBER ONE (June 11, 2010)

Other clearances for product code FAG

  • K821627 — THE ARTIFICIAL URINARY SPHINCTER (August 10, 1982)

FDA data resources