FDA.reportPublic FDA data

HENKE-SASS WOLF, GMBH.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80104183007130719HENKE-SASS WOLF, GMBH.1N2026-01-01KELTENSTRASSE 1 TUTTLINGEN Baden-Wurttemberg DE 78532

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
91961346481481K991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, CHIH1999-10-13
91961271524909K983067FINE-JECTFMI1998-10-30
91961810418326K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
91961654834086K962075HSW GMBH ARTHROSCOPEHRX1997-01-17
91961424197285K952186HSW GMBH HYSTEROSCOPES & ACCESSORIESHIH1996-02-06
91961317295312K941541HSV LAPAROSCOPY SETGCJ1994-05-16
91961564120356K821537HENKE DISPOSABLE SYRINGEFMF1982-05-28
91961992051222K173070HSW Resection InstrumentsHIH2018-06-08
91961458952269K171336Cystoscope 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
91961594696373K142414Miltex N-Tralig Intraligamentary SyringeEJI2014-10-30
91961193487840K121112STRYKER VIDEO URETEROSCOPEFGB2012-09-12
91961550554447K120659HU-FRIEDY DENTAL CARTRIDGE SYRINGEEJI2012-11-06
91961061621508K110097ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEEOB2011-05-27
91961697313275K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTEJI2009-03-09
91961191984383K082451STRYKER VIDEOSCOPEHET2008-12-16
91961155761015K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRX2008-03-18
91961528527443K050163HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPEGCJ2005-03-24
91961222686365K030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPEEOB2003-04-01
91961040177974
91961241203289
91961683115478
91962066656419
91961013951606
91961029938916
91961080578204
91961087324152
91961102083379
91961105319930
91961115734894
91961173586322
91961191984383
91961196404995
91961204418346
91961216507105
91961226073589
91961242654839
91961249026550
91961266891145
91961290167468
91961297760042
91961307549841
91961307821677
91961331374061
91961355951852
91961446505349
91961458514354
91961475026858
91961551616914
91961630351954
91961649416546
91961662498083
91961678609931
91961682798927
91961688116198
91961697445684
91961701553108
91961703842343
91961717326350
91961739397012
91961754102363
91961758989308
91961761967682
91961779666007
91961803494027
91961811284927
91961817531106
91961829821634
91961840999878
91961888600428
91961935130652
91961940534049
91961958644358
91961960742966
91961979318938
91962023036117
91962036545260
91962042680314
91962045758262
91962046441393
91962058153337

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIH32018-06-08
EJI32014-10-30
EOB32011-05-27
HRX22008-03-18
GCJ22005-03-24
FAJ12017-12-07
FGB12012-09-12
HET12008-12-16
FMI11998-10-30
FMF11982-05-28

PMN#