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510(k) K131282

NEXUS HEMORRHOID LIGATOR by Inx Medical — Product Code FHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2013
Date Received
May 6, 2013
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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  • 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)
  • K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNE (April 24, 2000)