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510(k) K882297

1/2 CM REAR TIP EXTENDER (RTE) by American Medical Systems, Inc. — Product Code FHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1988
Date Received
June 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Hemorrhoidal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

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  • 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 FHN

  • K213223 — Multi-Band Ligator (June 6, 2022)
  • K172985 — Ligation Device (June 14, 2018)
  • K150718 — Wi-3 HAL-RAR System (June 12, 2015)
  • K131282 — NEXUS HEMORRHOID LIGATOR (July 11, 2013)
  • K093497 — THD BANDY (July 15, 2010)
  • K091519 — HAEMOBAND MULTI-LIGATOR (July 28, 2009)
  • K070881 — LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (September 26, 2007)
  • K020824 — SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 (April 12, 2002)
  • K020526 — MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR (March 19, 2002)
  • K001236 — RIZA BAND STRETCHER (RBS)-60000 (July 17, 2000)