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XION GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
95150153003276727XION GmbH1N2026-01-01Pankstrasse 8 Berlin DE 13127

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3483271810418326K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
3483271317295312K941541HSV LAPAROSCOPY SETGCJ1994-05-16
3483271458952269K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathFAJ2017-12-07
3483271155761015K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRX2008-03-18
3483271528527443K050163HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPEGCJ2005-03-24
3483271307549841
3483272036545260

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ22005-03-24
FAJ12017-12-07
HRX12008-03-18
EOB11998-08-13

PMN#

GUDID#