FDA.reportPublic FDA data

SCHOELLY FIBEROPTIC, GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80439033002808088SCHOELLY FIBEROPTIC, GMBH1N2026-01-01ROBERT-BOSCH-STR. 1-3 DENZLINGEN Baden-Wurttemberg DE 79211

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
448811966746339K992527URETERO-RENOSCOPEFGB1999-10-13
448811576371035K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESHRX1999-08-06
448811598754121K965233SHARPSITE ACEOB1997-04-04
448811432747947K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)GCJ2024-06-20
448811576313979K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light SourceGCJ2023-02-23
448811894829966K201970Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH2020-10-08
448811279105240K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))HET2021-03-12
448811635321357K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
448811972935962K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY2017-06-13
448811699322366K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFGA2016-02-09
448812010499404K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH2015-03-09
448811681831483K143673CMOS Video Nasopharyngoscope SystemEOB2015-03-04
448811961558974K143221Schoelly LaparoscopeGCJ2014-12-05
448811136681183K142249SCHOELLY SINUSCOPEEOB2015-01-27
448811069109060K141366VIDEO BRONCHOSCOPE SYSTEMEOQ2014-12-17
448811877391829K133682SCHOELLY ARTHROSCOPEHRX2014-06-02
448811440350732K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
448811049033054K083553NASO-LARYNGO-PHARYNGOSCOPEEOB2009-01-16
448811201684268
448811347611571
448811018717593
448811081383406
448811111414803
448811421184142
448811431824883
448811644563557
448811646177118
448811748263437
448811762731146
448811825806156
448811885255693
448811924897156
448811927427987
448811947199672

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EOB42015-03-04
GCJ32024-06-20
NAY32019-07-26
HIH22020-10-08
HRX22014-06-02
HET12021-03-12
FGA12016-02-09
EOQ12014-12-17
FGB11999-10-13

PMN#