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510(k) K150718

Wi-3 HAL-RAR System by Agency For Medical Innovations GmbH — Product Code FHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2015
Date Received
March 19, 2015
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

Other clearances by Agency For Medical Innovations GmbH

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  • K182013 — EasyInstruments (March 11, 2019)
  • K182664 — FiXcision (December 7, 2018)
  • K092821 — TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 (February 1, 2010)

Other clearances for product code FHN

  • K213223 — Multi-Band Ligator (June 6, 2022)
  • K172985 — Ligation Device (June 14, 2018)
  • 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)
  • K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNE (April 24, 2000)