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510(k) K213223

Device
Multi-Band Ligator
Applicant
Beijing Zksk Technology Co., Ltd.
510(k) number
K213223
Product code
FHN
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-06
Date received
2021-09-29
Regulation
876.4400
Classification name
Ligator, Hemorrhoidal
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ma Li
Address
Bldg. 9, 6 & #6 Yuan Hengye N. 7th St., Yongle Economic Development Zone, Tongzho Beijing CN 101105 101105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FHN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172985Ligation DeviceLeo Medical Co., Ltd.2018-06-14
K150718Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH2015-06-12
K131282NEXUS HEMORRHOID LIGATORInx Medical2013-07-11
K093497THD BANDYThd Spa2010-07-15
K091519HAEMOBAND MULTI-LIGATORHaemoband Surgical, Ltd.2009-07-28
K070881LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660Sapimed S.P.A.2007-09-26
K020824SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238Boston Scientific Corp2002-04-12
K020526MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATORDon Wilson/Wilson-Cook Medical, Inc.2002-03-19
K001236RIZA BAND STRETCHER (RBS)-60000R-Med, Inc.2000-07-17
K000297ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGERErchinger Medizintecnik2000-04-24
K000397SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELBoston Scientific Corp2000-03-07
K981669SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATORBoston Scientific Corp1998-06-04
K974018WILSON-COOK 10 SHOT MULTI-BAND LIGATORWilson-Cook Medical, Inc.1998-01-20
K963166O'REGAN LIGATORPatrick J. O'Regan1997-05-05
K964079SPEEDBAND MULTIPLE BAND LIGATORBoston Scientific Corp1997-02-13