FDA 510(k) Applications for Medical Device Product Code "FHN"
(Ligator, Hemorrhoidal)

FDA 510(k) Number Applicant Device Name Decision Date
K150718 AGENCY FOR MEDICAL INNOVATIONS GMBH Wi-3 HAL-RAR System 06/12/2015
K213223 Beijing ZKSK Technology Co.,Ltd Multi-Band Ligator 06/06/2022
K952262 BOSTON SCIENTIFIC CORP. SPEEDBAND 02/29/1996
K964079 BOSTON SCIENTIFIC CORP. SPEEDBAND MULTIPLE BAND LIGATOR 02/13/1997
K981669 BOSTON SCIENTIFIC CORP. SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR 06/04/1998
K000397 BOSTON SCIENTIFIC CORP. SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL 03/07/2000
K020824 BOSTON SCIENTIFIC CORP. SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 04/12/2002
K020526 DON WILSON/WILSON-COOK MEDICAL, INC. MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR 03/19/2002
K000297 ERCHINGER MEDIZINTECNIK ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER 04/24/2000
K091519 HAEMOBAND SURGICAL LTD. HAEMOBAND MULTI-LIGATOR 07/28/2009
K131282 INX MEDICAL NEXUS HEMORRHOID LIGATOR 07/11/2013
K172985 Leo Medical Co., Ltd. Ligation Device 06/14/2018
K963166 PATRICK J. O'REGAN O'REGAN LIGATOR 05/05/1997
K001236 R-MED, INC. RIZA BAND STRETCHER (RBS)-60000 07/17/2000
K070881 SAPI MED S.P.A LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 09/26/2007
K960020 SURCRAFT LLC. SOLO BAND LIGATOR 04/01/1996
K093497 THD SPA THD BANDY 07/15/2010
K974018 WILSON-COOK MEDICAL, INC. WILSON-COOK 10 SHOT MULTI-BAND LIGATOR 01/20/1998


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