FDA Registration Active 🇩🇪 Germany

OLYMPUS WINTER & IBE GMBH

Reg #: 9610773 · FEI: 3002807798 · Expires 2026
Products
93
Proprietary Names
308
Establishment Types
6
Classifications
93

Registration Details

Registration Name
OLYMPUS WINTER & IBE GMBH
Registration Number
9610773
FEI Number
3002807798
Status
Active
Expiry Year
2026
Initial Importer
No
Address
KUEHNSTRASSE 61
City
HAMBURG
Country
DE

Regulatory Submissions

510(k) Number
K100275

Owner / Operator

Firm Name
OLYMPUS CORPORATION
Operator Number
9067818
Address
2951 ISHIKAWA-CHO
City
HACHIOJI-SHI
State
Tokyo
Postal Code
192-8507
Country
JP

US Agent

Business Name
Gyrus ACMI, Inc.
Contact Name
Todd Brill
Address
800 West Park Drive, --
City
Westborough
State
MA
ZIP
01581
Country
US
Phone
508 2077661

Products

Device Name Product Code
Block, Cutting, Ent, Non-Sterile NNR
Spatula, Surgical, General & Plastic Surgery GAF
Electrosurgical, Cutting & Coagulation & Accessories GEI
Electrode, Electrosurgical, Active, Urological FAS
Retractor, Ent KAL
Forceps, Ent KAE
Hysteroscope (And Accessories) HIH
Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
Chisel, Surgical, Manual FZO
Coagulator, Culdoscopic (And Accessories) HFI
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
Light, Surgical Headlight EBA
Apparatus, Exhaust, Surgical FYD
Laparoscope, General & Plastic Surgery GCJ
Tray, Surgical LRP
Endoscope, Ac-Powered And Accessories GCP
Bur, Ear, Nose And Throat EQJ
Saw, Nasal KBC
Laparoscope, Gynecologic (And Accessories) HET
Mirror, Headband, Ophthalmic HKF
Tray, Surgical, Ent MMO
Resectoscope, Working Element FDC
Mediastinoscope, Surgical EWY
Knife, Ear JYO
Resectoscope FJL
Speculum, Ent EPY
Cannula, Surgical, General & Plastic Surgery GEA
Arthroscope HRX
Curette, Ear JYG
Inserter, Myringotomy Tube JYM
Syringe, Irrigating (Non Dental) KYZ
Punch, Ent KTF
Accessories, Cleaning Brushes, For Endoscope MNL
Forceps, General & Plastic Surgery GEN
Dissector, Tonsil KBM
Urethroscope FGC
Telescope, Rigid, Endoscopic FBP
Hysteroscope Accessories NWW
Laryngoscope, Rigid CCW
Surgical Instruments, G-U, Manual (And Accessories) KOA
Laparoscope And Accessories, Gynecologic, Reprocessed NMH
Transilluminator, Fiber Optic MQW
System, Digital Image Communications, Radiological LMD
Tube, Smoke Removal, Endoscopic FCZ
Elevator, Ent KAD
Laryngostroboscope EQL
Endoscopic Access Overtube, Gastroenterology-Urology FED
Containment System, Laparoscopic Power Morcellation, With Instrument Port PMU
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Endoscope, Accessories, Narrow Band Spectrum NWB
Confocal Optical Imaging OWN
Insufflator, Hysteroscopic HIG
Gauge, Measuring JYJ
Display, Cathode-Ray Tube, Medical DXJ
Curette, Nasal KAP
Ureteroscope And Accessories, Flexible/Rigid FGB
Rongeur, Nasal KBB
Tray, Surgical, Instrument FSM
Led Light Source NTN
Scissors, General, Surgical LRW
Nasopharyngoscope (Flexible Or Rigid) EOB
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia QKA
Probe, Ent KAK
Kit, Nephroscope FGA
Fork, Tuning GWX
Instrument, Ligature Passing And Knot Tying HCF
Endoscope, Rigid GCM
Perforator, Ear-Lobe JYS
Instrument, Manual, Surgical, General Use MDM
Illuminator, Fiberoptic, Surgical Field HBI
Instrument, Ultrasonic Surgical LFL
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Knife, Ent KTG
Forceps, Biopsy, Electric KGE
Forceps HTD
Dilator, Tracheal KCG
Catheter And Tip, Suction JOL
Mirror, Ent KAI
Source, Carrier, Fiberoptic Light EQH
Mallet HXL
Cystoscope And Accessories, Flexible/Rigid FAJ
Electrode, Electrosurgical JOS
Trocar, Ent KTE
Instrument, Ent Manual Surgical LRC
Hook, Microsurgical Ear JYL
Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
Pump, Air, Non-Manual, For Endoscope FEQ
Urethrotome EZO
Rasp HTR
Tubing, Noninvasive GAZ

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) 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 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 Electrosurgical loops 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 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 Laryngeal scissors Sinuscope Resection Electrodes with HF cable Stopcock Accessory Hysteroscopic Sheath Probe Measuring instrument Rule 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 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 Laryngeal 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 Laryngeal forceps Dressing forceps Needle holder Ear forceps Pharyngeal forceps Towel forceps Gelfoam pressure forceps Swab forceps Turbinate forceps Septum forceps Adenoid forceps Nasal forceps Dilator Septum Needle Suction tupe Ureteroscopes, flexible and rigid, light source Mirror Head mirror Resection Sheath for Urology MAJ-900 Light carrier, fiber optic Throat microphone Light Source ESG-400 Mallet OES Elite Cystoscope and Accessories Disposable Lap. Instruments Resection Sheath for Hysteroscopy Trocar Killian Septum Speculum Buck Ear Currette Austin Tympanoplasty Richards Ritter-Halle Frontal Sinus Dilator Chest support Synergry Drill system Barnhill Adenoid Articulated arm and accessories Joseph Skin Hook Cottle Septum Speculum Bellucci Mic Scissors Double Spoon Biopsy Forceps RP Osteotome Delacruz measuring Russell-Davis Tongue Bld OTRP Trial Moriyama Univ. Cutt. Fcps Bojrab Dissector Hysteroscopes, forceps Pick Knot pusher Hook Introducer Ear hook Tracheal hook VERSAPOINT GENERATOR BALL ELECTRODE (5 PACK) SPRING ELECTRODE (5 PACK) TWIZZLE ELECTRODE (5 PACK) FOOTSWITCH (SMALL) PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL WB990310; WB990311; WB990210;WB990211 Electrosurgical Generator ESG-410 and Accessories ULTRA Telescopes (Sinuscopes) Disposable Electrosurgical Pencil Plastic Surgery System Flexible and rigid ureterotome system MCEND0550 Rasp Scoring instrument Raspatory Cartilage crusher Vacuum-powered body fluid suction apparatus Irrigation Bag Spike Assy Monopolar single-use HF cable Trocar System; Hasson PK Lap Loop PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM iTind system

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Foreign Private Label Distributor Manufacture Medical Device for Another Party (Contract Manufacturer)