FDA.reportPublic FDA data

510(k) K860863

Device
ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER
Applicant
GEORGE PERCY MCGOWN
510(k) number
K860863
Product code
LQC  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-15
Date received
1986-03-07
Regulation
876.4500
Classification name
Lithotriptor, Biliary Mechanical
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
300 SW 70 Ter. Pembroke Pines FL US 33023 33023

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LQC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040447TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088Boston Scientific Corp2004-03-12
K011178WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTORWilson-Cook Medical, Inc.2001-05-04
K964937A LITHOTRIPTER-COMPATIBLE BASKETBoston Scientific Corp1997-01-24
K942544GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETSMedi-Globe Corp.1994-11-22
K943191MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTORBoston Scientific Corp1994-08-29
K905552LAPAROLITHBaxter Healthcare Corp1991-12-17
K911364SPOON FORCEPS, 11MMNorthgate Technologies, Inc.1991-10-23
K911477LAPAROSCOPIC BASKET FLEXIBLE AND RIGIDUnited States Endoscopy Group, Inc.1991-08-14
K903529BML SERIESOlympus Corp.1991-01-23
K902170SOEHENDRA LITHOTRIPSY SETWilson-Cook Medical, Inc.1990-07-25

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases