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510(k) K020526

MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR by Don Wilson/Wilson-Cook Medical, Inc. — Product Code FHN

K020526 is an FDA 510(k) premarket notification submitted by Don Wilson/Wilson-Cook Medical, Inc. for the device "MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on March 19, 2002. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2002
Date Received
February 19, 2002
Clearance Type
Special
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 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)
  • K001236 — RIZA BAND STRETCHER (RBS)-60000 (July 17, 2000)
  • K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNE (April 24, 2000)

FDA data resources