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510(k) K821627

THE ARTIFICIAL URINARY SPHINCTER by American Medical Systems, Inc. — Product Code FAG

K821627 is an FDA 510(k) premarket notification submitted by American Medical Systems, Inc. for the device "THE ARTIFICIAL URINARY SPHINCTER". The FDA issued a decision of Substantially Equivalent on August 10, 1982. 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
August 10, 1982
Date Received
June 2, 1982
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

  • K912934 — AMS SPHINCTER 800 URINARY PROSTHESIS (March 18, 1992)

FDA data resources