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
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2023-11-16 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-11-07 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2023-11-07 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2007-11-30 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2023-11-16 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2023-11-16 |
| Coagulator, Culdoscopic (And Accessories) | HFI | Class 2 | Obstetrics/Gynecology | No | 2014-06-09 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2008-03-04 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2008-03-03 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2023-11-15 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2008-06-19 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2023-11-16 |
| Endoscope, Ac-Powered And Accessories | GCP | Class 2 | Gastroenterology, Urology | No | 2015-04-05 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2008-06-17 |
| Mirror, Headband, Ophthalmic | HKF | Class 1 | Ophthalmic | No | 2023-11-16 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2023-11-13 |
| Mediastinoscope, Surgical | EWY | Class 2 | Ear, Nose, Throat | No | 2023-11-15 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2023-11-07 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2008-03-03 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2008-03-03 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-11-15 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Inserter, Myringotomy Tube | JYM | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2023-11-16 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2008-03-03 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2008-03-03 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Urethroscope | FGC | Class 2 | Gastroenterology, Urology | No | 2023-11-15 |
| Telescope, Rigid, Endoscopic | FBP | Class 2 | Gastroenterology, Urology | No | 2023-11-15 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2012-10-22 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2008-03-03 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2008-03-03 |
| Laparoscope And Accessories, Gynecologic, Reprocessed | NMH | Class 2 | Obstetrics/Gynecology | No | 2023-11-14 |
| Transilluminator, Fiber Optic | MQW | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2021-02-01 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2023-11-16 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2023-11-15 |
| Containment System, Laparoscopic Power Morcellation, With Instrument Port | PMU | Class 2 | Obstetrics/Gynecology | No | 2023-11-15 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2023-11-07 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2014-06-09 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-11-15 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2020-07-21 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2020-07-21 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2020-07-21 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2023-11-15 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2023-11-15 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2008-06-19 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2008-03-03 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2023-11-14 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2008-03-03 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2023-11-15 |
| Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | QKA | Class 2 | Gastroenterology, Urology | No | 2026-05-26 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2008-06-19 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2008-03-03 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2008-03-03 |
| Endoscope, Rigid | GCM | Class 2 | Gastroenterology, Urology | No | 2020-04-06 |
| Perforator, Ear-Lobe | JYS | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2008-03-03 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 2023-11-15 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2012-02-13 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 1995-01-20 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2023-11-10 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2023-11-16 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-11-16 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2023-11-16 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2026-05-22 |
| Electrode, Electrosurgical | JOS | Class 2 | General, Plastic Surgery | No | 2023-11-07 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2008-03-03 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2023-11-16 |
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | Class 2 | Obstetrics/Gynecology | No | 2008-03-07 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2023-11-07 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2023-11-07 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2023-11-16 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2008-03-03 |
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)