FDA.reportPublic FDA data

OLYMPUS WINTER & IBE GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96107733002807798OLYMPUS WINTER & IBE GMBH1N2026-01-01KUEHNSTRASSE 61 HAMBURG DE 22045

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04042761081757Olympus - WA97013A+1(800)401-1086xx@xx.xx
04042761082297Olympus - Light-guide cable, 2.8 mm, 3 m, CF type+1(800)401-1086xx@xx.xx
04042761082303Olympus - Light-guide cable, 4.25 mm, 3 m, CF type+1(800)401-1086xx@xx.xx
04042761083102Olympus - WT218700+1(800)401-1086xx@xx.xx
04042761083119Olympus - WT218705+1(800)401-1086xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3223441957900258K994418VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH2000-01-24
3223441988984750K992901GYNECARE VERSAPOINT G-VAP ELECTRODEHIH2000-01-18
3223441971835596K992141OLYMPUS WORKING ELEMENT FOR PROBESFDC1999-09-29
3223441529946676K990237TROCAR SYSTEM ACCORDING TO HASSONGCJ1999-07-12
3223441562382610K984417BIPOLAR GRASPING FORCEPS BIQ+GEI1999-02-24
3223441874874457K983811UNIPOLAR OPTICAL BIOPSY FORCEPSKGE1998-12-24
3223441144881466K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH1999-03-01
3223441467102918K962482SCUBA SYSTEMHIH1996-11-01
3223441573576785K955623OLYMPUS BIPOLAR FORCEPSGEI1996-02-13
3223441558986347K954488ROLLER ELECTRODEHIH1997-03-06
3223442023097842K951863ROLLER ELECTRODEFAS1995-08-24
3223441125800326K951855ULTRATHIN URETEROSCOPESFGB1995-08-16
3223441245740833K951354OLYMPUS ARTHROSCOPY SYSTEMHRX1995-06-14
3223441525681210K950278MINI LAPAROSCOPY FOR GENERAL SURGERYGCJ1995-02-01
3223441657959478K950076LAPAROSCOPEGCJ1995-03-03
3223441199635557K950055A4722 OLYMPUS OPTICAL OBTURATORHIH1995-02-21
3223441971037287K944201HI-Q HAND INSTRUMENTS- UROLOGYGCJ1994-11-29
3223441420505752K944200HI-Q HAND INSTRUMENTS, OB/GYN USEHET1995-09-15
3223441443526622K944072OLYMPUS NASAL AND SINUS ENDOSCOPESEOB1995-01-11
3223441306126453K936304ELECTROSURGICAL PENCILGEI1994-06-13
3223441707483864K931995RESECTOSCOPE SHEATHFJL1993-07-23
3223441111102156K931994RESECTOSCOPE SHEATHHIH1994-02-17
3223441338841457K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCESHIH1994-06-08
3223441638060166K931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSFAS1994-08-29
3223441719134897K930041VICROSAFE 6 AND VICROSAFE 12FYD1993-11-03
3223441537175841K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMFYD1993-09-13
3223441009267201K923982OLYMPUS OES LAPAROSCOPY SYSTEMGCJ1993-03-15
3223441772040401K912362OES THORACOSCOPE SYSTEMEWY1991-10-24
3223441827909346K904940OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIESFJL1992-01-13
3223441519846883K904939FLEXIBLE AND RIGID URETEROTOME SYSTEMEZO1992-01-07
3223441697543841K903323RESECTOSCOPE LOOPSKNS1990-10-01
3223442030118316K897003OLYMPUS HYSTERORESECTOSCOPEHIH1990-03-16
3223441339395906K891451OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPEHIH1989-10-02
3223441796616989K853486OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPEFGA1985-09-12
3223441079697837K852888OLYMPUS RIGID URETERORENOSCOPEFGB1985-08-21
3223441179438487K790071ENDOSCOPE AND ACCESSORIESGCP1979-04-02
3223441184200087K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,FAJ2026-05-21
3223441698655512K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)GEI2025-09-23
3223441541432799K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)GEI2023-08-18
3223442013145283K221522HF-cables (resusable)GEI2023-01-19
3223441220853321K213207Sheath, Stopcock AccessoryHIH2021-12-22
3223441090721589K210651Resection Electrodes with HF cableFAS2021-08-03
3223441981056852K210138iTind SystemQKA2021-06-25
3223441344311858K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double ActionGEI2021-05-17
3223441209702501K203492Instrument tray, for semi-rigid ureteroscopeKCT2021-09-15
3223441793250497K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsGEI2021-04-28
3223441031791679K200770Mini PCNL-SystemFED2021-07-30
3223441025950960K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera HeadOWN2020-07-17
3223441102034770K200369OES Elite Ureteroscopes and AccessoriesFGB2020-08-28
3223441800401207K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DGCJ2020-04-03
3223441527941499K192898PneumoLinerPMU2020-02-25
3223441993721631K190744ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)HET2019-08-29
3223441444757744K182587Device Electrosurgical Generator ESG-150GEI2018-11-29
3223441054585225K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesGEI2018-04-26
3223441515930370K173877BOWA Neutral ElectrodesGEI2018-02-15
3223441178109135K171965Resection Electrodes with HF cableFAS2017-09-28
3223441078891980K171692Instrument basket, for EndoEYEKCT2018-04-02
3223441941368085K161600Resection ElectrodesJOS2016-09-06
3223441281224653K160639Electrosurgical Generator ESG-200GEI2016-05-04
3223441950883730K160249ULTRA TelescopesHRX2016-04-21
3223441417266869K160053Monopolar single-use HF cableGEI2016-05-06
3223441136710703K153009ULTRA TelescopesEOB2016-04-05
3223441599742356K152092Resection ElectrodesFAS2015-10-26
3223442047809943K151191OES ELITE Telescopes, Protective TubeFBP2015-11-24
3223441306385916K150633ULTRA TelescopesGCJ2015-04-29
3223441515310601K150024Bissinger Monopolar CablesGEI2015-02-20
3223441632171139K142525PK Lap LoopHIN2014-11-21
3223441831273386K142249SCHOELLY SINUSCOPEEOB2015-01-27
3223441251714861K140624HICURA HAND INSTRUMENTSGEI2014-12-10
3223441477756872K133311ENDOLEDNTN2014-07-30
3223441418676496K131402VISICLEAR SMOKE EVACUATION SYSTEMFYD2014-03-03
3223441595176303K123732HYSTEROSCOPY PUMP HM6HIG2013-04-04
3223441092487842K122167NEXXIS ORDXJ2013-04-22
3223441512611573K120418ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIESFAS2012-06-20
3223441122826337K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSHIN2011-12-02
3223441287041279K111342LIGHT GUIDE CABLEHBI2011-11-25
3223441496476020K111202SURGICAL TISSUE MANAGEMENT SYSTEMGEI2012-01-20
3223441860141377K110748OLYMPUS INSTRUMENT TRAYKCT2012-02-15
3223441583996503K103375PLUMEPEN INTEGRATED SMOKE EVACUATION PENCILGEI2011-03-16
3223441287207010K100275WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDSFAS2010-07-01
3223441473547237K090980HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015LNWB2009-06-29
3223441143726426K073207OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167GEI2008-05-08
3223441979265614K070812DISPOSABLE LAPAROSCOPIC INSTRUMENTGEI2007-09-14
3223441159968560K040302VERSAPOINT RESECTOSCOPIC SYSTEMHIH2004-03-09
3223441846425594K033222OLYMPUS STERILIZATION TRAYSKCT2004-08-02
3223441797463257K032838CELON ENT SYSTEMGEI2003-09-26
3223441404097077K030194XUES-41 ENDOSCOPIC ELECTROSURGICAL UNITKNS2003-03-24
3223441980948139K022449HYSTEREOSCOPY PUMP HM4HIG2003-04-10
3223441793849393K000904PENADAPT 10FYD2000-06-08
3223441484836743DEN190020iTind SystemQKA2020-02-25
3223441039080198DEN150028PneumoLinerPMU2016-04-07
3223441009080247
3223441011811875
3223441063718910
3223441074565239
3223441088463144
3223441091514246
3223441099214744
3223441117928064
3223441121717328
3223441135956332
3223441150055460
3223441153725885
3223441203193204
3223441209466865
3223441262658093
3223441284485790
3223441300448446
3223441342081356
3223441343254714
3223441345782626
3223441362016210
3223441401757430
3223441419894466
3223441426062678
3223441426933789
3223441429401467
3223441434627787
3223441437180804
3223441455478610

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI202025-09-23
HIH122021-12-22
FAS72021-08-03
GCJ72020-04-03
KCT42021-09-15
FYD42014-03-03
FGB32020-08-28
EOB32016-04-05
QKA22021-06-25
PMU22020-02-25
HET22019-08-29
HRX22016-04-21
HIN22014-11-21
HIG22013-04-04
KNS22003-03-24
FJL21993-07-23
FAJ12026-05-21
FED12021-07-30
OWN12020-07-17
JOS12016-09-06
FBP12015-11-24
NTN12014-07-30
DXJ12013-04-22
HBI12011-11-25
NWB12009-06-29
FDC11999-09-29
KGE11998-12-24
EZO11992-01-07
EWY11991-10-24
FGA11985-09-12
GCP11979-04-02

PMN#

ENDOLED

2014-07-30

OLYMPUS WINTER & IBE GMBH

GUDID#

200 records. Showing 1-40. Next