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510(k) K920643

Device
LAPAROSCOPIC SUCTION/IRRIGATION PROBE
Applicant
O.R. CONCEPTS, INC.
510(k) number
K920643
Product code
GBZ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-06
Date received
1992-02-12
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN MAYALL
Address
200 N. Oak St. Roanoke TX US 76262 76262

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K942450ENDOPATHEthicon Endo-Surgery, Inc.1994-08-05
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
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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