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ADVANCED SURGICAL CONCEPTS (ASC)

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96167203003283598ADVANCED SURGICAL CONCEPTS (ASC)1N2020-04-25UNIT 4, SUNNYBANK CENTRE BRAY Wicklow IE --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
568071238612996K121309ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEOTJ2012-09-06
568071374106102K111407TRIPORT, TRIPORT+, TRIPORT15, QUADPORTOTJ2012-01-18
568071406834034K110004ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEOTJ2011-01-26
568071107183725K101794ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WAOTJ2010-11-29
568071157371450K073719ASC TRIPORT LAPAROSCOPIC ACCESS DEVICEGCJ2008-01-29
568071377263313DEN150028PneumoLinerPMU2016-04-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OTJ42012-09-06
PMU12016-04-07
GCJ12008-01-29

PMN#