FDA.reportPublic FDA data

James Bonneville

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146442763006149253James Bonneville1N2026-01-01360 Church St. Suite 130 Northborough MA US 01532
30061492533006149253James Bonneville1N2020-04-25360 Church St. Suite 130 Northborough MA US 01532

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2282051966746339K992527URETERO-RENOSCOPEFGB1999-10-13
2282051576371035K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESHRX1999-08-06
2282051047649484K971253VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTSHRX1997-06-13
2281631598754121K965233SHARPSITE ACEOB1997-04-04
2282051598754121K965233SHARPSITE ACEOB1997-04-04
2282051456899104K951990LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPEGCJ1995-09-08
2282051972935962K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY2017-06-13
2282051699322366K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFGA2016-02-09
2282052010499404K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH2015-03-09
2282051681831483K143673CMOS Video Nasopharyngoscope SystemEOB2015-03-04
2282051961558974K143221Schoelly LaparoscopeGCJ2014-12-05
2282051136681183K142249SCHOELLY SINUSCOPEEOB2015-01-27
2282051877391829K133682SCHOELLY ARTHROSCOPEHRX2014-06-02
2282051440350732K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
2282051018717593K101077DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100GCJ2011-02-04
2282051049033054K083553NASO-LARYNGO-PHARYNGOSCOPEEOB2009-01-16
2282051431824883K081137INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000NAY2009-02-18
2282051644563557K080155MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEMGCJ2008-03-06
2282051927427987K0142507MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114GCJ2002-01-10
2282051081383406
2282051421184142
2282051646177118
2281631018717593
2281631049033054
2281631081383406
2281631136681183
2281631421184142
2281631431824883
2281631432747947
2281631576313979
2281631644563557
2281631646177118
2281631681831483
2281631699322366
2281631877391829
2281631885255693
2281631924897156
2281631927427987
2281631961558974
2281631966746339
2281632010499404

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EOB52015-03-04
GCJ52014-12-05
NAY32017-06-13
HRX32014-06-02
FGA12016-02-09
HIH12015-03-09
FGB11999-10-13