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510(k) K942450

Device
ENDOPATH
Applicant
ETHICON ENDO-SURGERY, INC.
510(k) number
K942450
Product code
GBZ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-05
Date received
1994-05-23
Regulation
878.4200
Classification name
Catheter, Cholangiography
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CLAUDIA L BERNER
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 GBZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973621PRE-VIEW CHOLANGIOGRAPHY CLAMPNashville Surgical Instruments1997-12-17
K944790FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERApplied Medical Resources1994-11-29
K932228MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETERBoston Scientific Corp1993-08-10
K926217TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USETerumo Medical Corp.1993-07-13
K926143ANGIOLAPCATH CHOLANGIOGRAPHY KITBd Becton Dickinson Vacutainer Systems Preanalytic1993-07-07
K924212STRYKER ENDOSCOPY CHOLANGIOGRAM KITStryker Corp.1993-07-07
K925742CLARUS CHOLANGIOGRAM CATHETER KITClarus Medical Systems, Inc.1993-06-01
K924981OPERATIVE CHOLANGIOGRAM CATHETERTaut, Inc.1993-04-06
K924480CHOLANGIOGRAPHY CLAMPApplied Medical Resources1993-03-03
K924128CHOLANGIOGRAPHY CATHETERApplied Medical Resources1993-02-10
K921091CHOLANGIOLAPCATH(TM)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-05-06
K920643LAPAROSCOPIC SUCTION/IRRIGATION PROBEO.R. Concepts, Inc.1992-05-06
K914015CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMPPilling Co.1991-11-21
K903709SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATHLifestream Int'L, Inc.1990-10-26
K901520WURTZ CHOLEY CLIP (TM)Cd Medical, Inc.1990-06-26

Legacy Summary#

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FDA Review#

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