OLYMPUS WINTER & IBE GMBH

FDA Device Registration & Listing · HAMBURG, DE · Registration 9610773

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610773
FEI Number
3002807798
Entity Name
OLYMPUS WINTER & IBE GMBH
City/State/Country
HAMBURG, DE
Establishment Address
KUEHNSTRASSE 61, HAMBURG 22045, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
OLYMPUS CORPORATION (Owner Number: 9067818)
Owner / Operator Contact Address
2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Cutting jig Cutting block Teeth protector Spatula Tongue depressor HF Resection Electrode Retractor and accessories Tonsil forceps Dissection forceps Grasping forceps Artery forceps HFY Hysteroscopes and telescopes Tubing Gouge Osteotome Chisel Versapoint GVAP LOOP ELECTRODE (5 PACK) (VRS ANGLED LOOP RESECTOSCOPE ELECTRODE) GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE) PENADAPT 10 OLYMPUS OES LAPAROSCOPY SYSTEM Rack Kidney bowl Medicine cup Round bowl Tray Cysto-urethroscopes and forceps Irrigating Blade Diamond Burrs Diego Blades Viper Mastoid Burrs Mastoid Round Cutting Burrs Dermabrader Stapes Cutting Burrs Burr Saw WA91302W WA91307W WA91303W WA91301W PK-CF0533 WA91307C ESG-150 HI-Q HAND INSTRUMENTS, OB/GYN USE Head band Bipolar Grasping Forceps BiQ+ Roller Electrodes for OB/Gyn Jar, stainless steel Glass tray Working Elements and insert Mediastinoscope Sheehy Weapon Sheehy Flap Knife HF Resection Electrode Loop with Runner Hi-Q Instruments Boucheron Ear Speculum Holmgren Speculum Hartmann Ear Speculum Politzer Ear Speculum Gruber Ear Speculum Speculum and accessories Cannula Septum Cannula Mandrin, for Suction tubes Suction tube ULTRA Telescopes (Arthroscopes) HF Resection Electrode Loop with Runner Spare rod, vertical, for nasal snare Ear forceps, inserter for ventilation tubes Inserter, for T-Tubes Syringe Punch forceps FTL-DEK-B BW-400V BW-403B MAJ-1339 BW-400B BW-411B BW-412T MAJ-1888 BW-400L Cleaning Accessory FTL-DEK-A Single Use Cleaning Brush E8213 GEN. SURGERY FORCEPS Dissector Tonsil dissector and retractor OES ELITE Telescopes, Protective Tube Arthroscopes, CLV-S20 light source OLYMPUS BIPOLAR FORCEPS AND ACCESSORIES Hysteroscope accessories FG-54D FG-52D Operation laryngoscope CELON ENT SYSTEM Pressure Reducer ESG-300 MAPC Probes Grasping forceps Scissors E8218 Biopsy forceps Ultra telescopes Light clip Light carrier HF Resection Electrodes Tubing, sterile, for UHI smoke evacuation CELON ELITE ESG-200 Elevator Suction elevator LIGHT SOURCE FOR STROBOSCOPY LARYNGOSTROBOSCOPE Mini PCNL-System PneumoLiner HF Resection Electrodes Electrosurgical loops Versapoint Optical Obturator Instrument basket, for EndoEYE PNEUMOLINER Instrument tray, for semi-rigid ureteroscope Telescope "IR" CH-S200-XZ-EB CH-S200-XZ-EA OTV-S200 Telescope "ULTRA" CLV-S200-IR HYSTEROSCOPY PUMP Gauge pin Neutral electrode cable MNT-120 H.264 MNA-110 ENC DVI MNA-110 ENC DP MNA-120 DEC DVI AUDIO MNA-240 Ouad Decoder MNA-120 ENC HDSDI AUDIO MNA-120 ENC DVI AUDIO MNA-110 ENC HDSDI MNA-120 ENC DP AUDIO Ear loop Polyp snare Loop Ear curette Tube set Hicura Hand Instruments HD Endoeye OLYMPUS RIGID URETERORENOSCOPE VICROSAFE 6 AND VICROSAFE 12 OLYMPUS STERILIZATION TRAYS Olympus KeyMed Instrument Tray A5961, A5976, A05951A, A05961A,WA05970A, WA05971A , WA05972A, WA05973A, WA05974A, WA05990A, WA05994A, WA05995A HF Resection electrode, cylinder Bone rongeur ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) Endoscopic instrument sterilization trays Various sterilization trays Diego instrument sterilization tray Tray EndoLED Light Source Rhinoplasty scissors Bandage scissors Nasal scissors Wire curring scissors Ethmoid scissors Strabismus scissors Ear scissors Tonsil scissors Dissection scissors Iris scissors Ligature scissors Scissors Laryngeal scissors Sinuscope Resection Electrodes with HF cable Stopcock Accessory Hysteroscopic Sheath Probe Measuring instrument Rule Versapoint Rigid and percutaneous nephroscope Tuning fork Noise apparatus Needle, for fascial closure MAJ-1912 MAJ-1921 Visera Elite II Endoeye 3D MAJ-2316 Knife Hand peforator Needle Peforator Tonsil needle Infant resectoscope OES Elite Ureteroscopes and Accessories Thorascoscope system TFL-AFC-NS, TFL-AFS150-NS, TFL-AFS200-NS, TFL-AFS365-NS, TFL-AFS550-NS, TFL-AFS940-NS Tip cleaner Holster MINI LAPAROSCOPY FOR GENERAL SURGERY Light-guide cable Syringe MAJ-1870 MAJ-1869 ESG-100, AFU-100 MAJ-1873 MAJ-1872 MAJ-1871 MAJ-1876 Steritray OLYMPUS NASAL AND SINUS ENDOSCOPES HF-cables (reusable) MAJ-1453 MAJ-1119 MAJ-422 MAJ-1193 Leakage Tester Adapter Light-guide Adapter Cleaning Accessories Dissector Laryngeal knife Knife Swivel knife Round knife Ear knife Lancet knife Roller knife Incision knife Sickle knife Scalpel handle Tonsil knife Adenotome WA94020A HF cable "EndoTherapy", monopolar Unipolar Optical Biopsy Forceps Clip applier Thumb forceps Cotton applicator Tonsil forceps Laryngeal forceps Dressing forceps Needle holder Ear forceps Grasping forceps Pharyngeal forceps Biopsy forceps Towel forceps Gelfoam pressure forceps Swab forceps Turbinate forceps Septum forceps Punch forceps Adenoid forceps Nasal forceps Dilator Septum Needle Suction tupe Ureteroscopes, flexible and rigid, light source

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NNR Block, Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2023-11-16
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-11-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-07
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-11-07
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2008-03-03
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2008-03-03
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2007-11-30
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2023-11-16
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2023-11-16
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2014-06-09
HFI Coagulator, Culdoscopic (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2014-06-09
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2008-03-04
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2008-03-04
EBA Light, Surgical Headlight Dental Class 1 872.4630 2008-03-03
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2023-11-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-06-19
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2023-11-16
GCP Endoscope, Ac-Powered And Accessories Gastroenterology, Urology Class 2 876.1500 2015-04-05
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2008-03-03
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 2023-11-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-09-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-13
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2008-06-17
HKF Mirror, Headband, Ophthalmic Ophthalmic Class 1 886.1500 2023-11-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-10
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-11-07
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2008-03-03
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2023-11-13
EWY Mediastinoscope, Surgical Ear, Nose, Throat Class 2 874.4720 2023-11-15
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2023-11-16
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-11-07
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2023-11-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-08-26
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2008-03-03
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-03-03
HRX Arthroscope Orthopedic Class 2 888.1100 2023-11-15
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-11-07
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2023-11-16
JYM Inserter, Myringotomy Tube Ear, Nose, Throat Class 1 874.4420 2023-11-16
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2023-11-16
KTF Punch, Ent Ear, Nose, Throat Class 1 874.4420 2008-03-03
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2008-03-03
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-03-03
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2023-11-16
FGC Urethroscope Gastroenterology, Urology Class 2 876.1500 2023-11-15
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-11-15
FBP Telescope, Rigid, Endoscopic Gastroenterology, Urology Class 2 876.1500 2023-11-15
HRX Arthroscope Orthopedic Class 2 888.1100 2023-11-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-10
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2012-10-22
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2008-03-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-13
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2008-03-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-11-14
NMH Laparoscope And Accessories, Gynecologic, Reprocessed Obstetrics/Gynecology Class 2 884.1720 2023-11-14
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2023-11-14
MQW Transilluminator, Fiber Optic Ear, Nose, Throat Class 1 874.4350 2023-11-16
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2021-02-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-07
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-11-07
FCZ Tube, Smoke Removal, Endoscopic Gastroenterology, Urology Class 1 876.1500 2023-11-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-09
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2008-03-03
EQL Laryngostroboscope Ear, Nose, Throat Class 1 874.4750 2023-11-16
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-11-15
PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port Obstetrics/Gynecology Class 2 884.4050 2023-11-15
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2023-11-07
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-11-07
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-11-07
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-11-07
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2014-06-09
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2014-06-09
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-11-14
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-11-15
PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port Obstetrics/Gynecology Class 2 884.4050 2023-11-15
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-11-15
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2020-07-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-07-21
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-07-21
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2020-07-21
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2020-07-21
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2023-11-15
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 2023-11-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-15
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2023-11-15
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2023-11-16
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2023-11-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-14
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2025-03-14
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2008-06-19
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2023-11-15
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-11-10
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2008-06-17
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2008-06-17
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 2023-11-16
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-06-16
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2023-11-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-11-15
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2023-11-15
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2008-03-03
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2023-11-14
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2008-03-03
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2023-11-15
QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia Gastroenterology, Urology Class 2 876.5510 2026-05-26
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-11-07
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-11-07
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2023-11-07
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-11-15
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2008-03-03
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2014-05-22
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2014-05-22
FGA Kit, Nephroscope Gastroenterology, Urology Class 2 876.1500 2008-06-19
GWX Fork, Tuning Neurology Class 1 882.1525 2008-03-03
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2008-03-03
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-04-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-04-06
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2020-04-06
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2020-04-06
GCM Endoscope, Rigid Gastroenterology, Urology Class 2 876.1500 2020-04-06
JYS Perforator, Ear-Lobe Ear, Nose, Throat Class 1 874.4420 2023-11-16
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2007-11-30
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-11-15
EWY Mediastinoscope, Surgical Ear, Nose, Throat Class 2 874.4720 1995-10-18
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2008-03-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-06-20
HBI Illuminator, Fiberoptic, Surgical Field General, Plastic Surgery Class 2 878.4580 2023-11-15
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2023-11-15
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2012-02-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-02-13
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2012-02-13
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-11-14
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2008-12-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-15
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology Class 1 876.1500 1995-01-20
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2008-03-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-15
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2023-11-10
HTD Forceps General, Plastic Surgery Class 1 878.4800 2023-11-16
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2008-03-03
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2023-11-16
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2008-01-18

Official Correspondent

No official correspondent registered.

US Agent Details

Todd Brill Business: Gyrus ACMI, Inc. Email: todd.brill@olympus.com Phone: (508) 2077661

Related Public Records

Same Entity

OLYMPUS CORPORATION
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Other Registrations for Same Entity

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610773. Last updated year: 2026. Please use registration number 9610773 when referencing this establishment in official correspondence.
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