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FHN — Ligator, Hemorrhoidal Class II

FDA Device Classification

Classification Details

Product Code
FHN
Device Class
Class II
Regulation Number
876.4400
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213223beijing zksk technology coMulti-Band LigatorJune 6, 2022
K172985leo medical coLigation DeviceJune 14, 2018
K150718agency for medical innovationsWi-3 HAL-RAR SystemJune 12, 2015
K131282inx medicalNEXUS HEMORRHOID LIGATORJuly 11, 2013
K093497thdTHD BANDYJuly 15, 2010
K091519haemoband surgicalHAEMOBAND MULTI-LIGATORJuly 28, 2009
K070881sapimedLEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660September 26, 2007
K020824boston scientificSPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 April 12, 2002
K020526don wilson/wilson-cook medicalMODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATORMarch 19, 2002
K001236r-medRIZA BAND STRETCHER (RBS)-60000July 17, 2000
K000297erchinger medizintecnikERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEApril 24, 2000
K000397boston scientificSPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBANMarch 7, 2000
K981669boston scientificSPEEDBAND SUPERVIEW MULTIPLE BAND LIGATORJune 4, 1998
K974018wilson-cook medicalWILSON-COOK 10 SHOT MULTI-BAND LIGATORJanuary 20, 1998
K963166patrick j. o'reganO'REGAN LIGATORMay 5, 1997
K964079boston scientificSPEEDBAND MULTIPLE BAND LIGATORFebruary 13, 1997
K960020surcraftSOLO BAND LIGATORApril 1, 1996
K952262boston scientificSPEEDBANDFebruary 29, 1996
K882297american medical systems1/2 CM REAR TIP EXTENDER (RTE)June 17, 1988
K880648superior healthcare groupENDOSCOPIC ELASTIC BAND LIGATORApril 6, 1988