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510(k) K051950

Device
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
Applicant
ETHICON ENDO-SURGERY, INC.
510(k) number
K051950
Product code
MND  
Decision
Substantially Equivalent (SESE)
Decision date
2005-10-07
Date received
2005-07-18
Regulation
876.4400
Classification name
Ligator, Esophageal
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
KIMBERLY SHOEMAKER
Address
4545 Creek Rd. Cincinnati OH US 45242 45242

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MND  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132535AUTOBAND LIGATOREndochoice, Inc.2013-08-23
K083556MODIFICATION TO AUTO-BAND LIGATORScandimed International2009-02-19
K081142AUTO-BAND LIGATORScandimed International2008-05-16
K031236AUTO-BAND LIGATORScandimed. A.S.2003-11-14
K033245BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700UC.R. Bard, Inc.2003-11-06
K022434BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700UC.R. Bard, Inc.2002-08-05
K013066HX-5/6-1 ENDOSCOPIC CLIPPING DEVICEOlympus America, Inc.2001-12-11
K001744OLYMPUS ENDOSCOPIC LIGATION DEVICEOlympus America, Inc.2001-02-27
K990864SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228Boston Scientific Corp1999-06-11
K984255OLYMPUS HX-20 SERIES LIGATING DEVICEOlympus Corp of America1999-01-12
K964661HX-20/21-1 ENDOSCOPIC LIGATOROlympus America, Inc.1997-10-30
K971137BARD RAPIDFIRE MULTIPLE BAND LIGATORC.R. Bard, Inc.1997-10-16
K944220WILSON COOK MULTIPLE BAND LIGATORWilson-Cook Medical, Inc.1995-01-24
K940661STIEGMANN-GOFF ENDOSCOPIC LIGATORC.R. Bard, Inc.1994-11-28

Legacy Summary#

summary

FDA Review#

Decision Summary