FDA Registration
Active
🇩🇪 Germany
RICHARD WOLF GMBH
Reg #: 9611102
·
FEI: 3002808001
·
Expires 2026
Products
167
Proprietary Names
9
Establishment Types
5
Classifications
167
Registration Details
- Registration Name
- RICHARD WOLF GMBH
- Registration Number
- 9611102
- FEI Number
- 3002808001
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PFORZHEIMER STR. 32
- City
- KNITTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K003164
Owner / Operator
- Firm Name
- RICHARD WOLF GMBH
- Operator Number
- 8010049
- Address
- PFORZHEIMER STR. 32, --
- City
- KNITTLINGEN
- State
- DE-NOTA
- Postal Code
- 75438
- Country
- DE
- Correspondent
- Ute Greiner
US Agent
- Business Name
- RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- Contact Name
- Lisa Williams
- Address
- 353 CORPORATE WOODS PKWY.
- City
- VERNON HILLS
- State
- IL
- ZIP
- 60061
- Country
- US
- [email protected]
- Phone
- 847 9131113 ext. 225
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 1994-05-09 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1998-02-20 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1998-03-24 |
| Probe | HXB | Class 1 | Orthopedic | No | 1998-02-20 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2000-05-17 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2016-09-19 |
| Spoon, Ear | JZE | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2019-05-06 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2019-05-06 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2019-05-06 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-09-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-09-20 |
| Camera, Television, Surgical, With Audio | FWC | Class 1 | General, Plastic Surgery | No | 2016-09-20 |
| Camera, Television, Endoscopic, With Audio | FWG | Class 1 | General, Plastic Surgery | No | 2016-09-20 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 1998-03-11 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2014-10-31 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2016-03-01 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2020-07-13 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2016-09-19 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2012-10-22 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2012-10-22 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2016-09-19 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2022-12-15 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2022-01-18 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2010-04-08 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2010-04-08 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2010-04-08 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2000-04-24 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 1998-03-12 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 1986-05-09 |
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 1978-03-31 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2016-09-19 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1998-02-20 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 1998-03-12 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2018-09-24 |
| Endoscope, Rigid | GCM | Class 2 | Gastroenterology, Urology | No | 2009-05-11 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 1998-02-04 |
| Laser, Neodymium:Yag, Pulmonary Surgery | LLO | Class 2 | Ear, Nose, Throat | No | 2016-09-19 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 1978-03-31 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2013-09-05 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1998-02-20 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 1997-08-26 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 1978-03-31 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 1999-03-31 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2011-07-26 |
| Telescope, Rigid, Endoscopic | FBP | Class 2 | Gastroenterology, Urology | No | 2016-09-20 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2014-09-08 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2010-03-30 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2010-03-30 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 1986-05-09 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2013-10-28 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2013-10-28 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2013-10-28 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2009-11-18 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2009-11-18 |
| Modular Electromechanical Surgical System | SCV | Class 2 | General, Plastic Surgery | No | 2026-01-13 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Elevator, Uterine | HDP | Class 2 | Obstetrics/Gynecology | No | 2011-07-29 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2011-07-29 |
| Trocar, Gastro-Urology | FBQ | Class 2 | Gastroenterology, Urology | No | 2016-09-20 |
| System, Abortion, Vacuum | HHI | Class 2 | Obstetrics/Gynecology | No | 2016-05-25 |
| Endoscopic Central Control Unit | ODA | Class 2 | Gastroenterology, Urology | No | 2016-09-19 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Cable | ISN | Class 1 | Physical Medicine | No | 1997-10-01 |
| Yoke Assembly, Medical Gas | CAM | Class 1 | Anesthesiology | No | 1997-10-01 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Headlight, Fiberoptic Focusing | FCT | Class 2 | Ophthalmic | No | 2018-09-24 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 1998-03-24 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 2001-08-24 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2016-09-20 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 1997-10-01 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2016-09-20 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2010-03-10 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2013-10-28 |
| Lens, Camera, Surgical | FXQ | Class 1 | General, Plastic Surgery | No | 2013-04-05 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 1998-10-15 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2015-12-28 |
| Laser, Surgical, Gynecologic | HHR | Class 2 | Obstetrics/Gynecology | No | 2016-09-19 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2016-08-23 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2016-08-23 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 1998-02-20 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2010-03-30 |
| Laparoscopic Single Port Access Device | OTJ | Class 2 | Gastroenterology, Urology | No | 2012-08-09 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2014-09-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2001-02-22 |
| Obturator, For Endoscope | FEC | Class 2 | Gastroenterology, Urology | No | 2010-03-10 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2010-03-10 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2009-06-18 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 1998-03-24 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 1998-03-11 |
| Cystourethroscope | FBO | Class 2 | Gastroenterology, Urology | No | 2009-04-30 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Basin For Endoscope Reprocessing | PHT | Class 1 | Gastroenterology, Urology | No | 2023-09-27 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2009-11-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-12-28 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 1998-03-24 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 1997-10-01 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2016-06-29 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2004-10-04 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 1998-03-12 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2016-09-20 |
| Monitor, Line Isolation | DRI | Class 1 | Cardiovascular | No | 2016-01-11 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 1978-03-31 |
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | Class 2 | Obstetrics/Gynecology | No | 2016-09-20 |
| Needle, Gastro-Urology | FHR | Class 1 | General, Plastic Surgery | No | 2024-03-11 |
| Set, Laryngeal Injection | KAA | Class 1 | Ear, Nose, Throat | No | 2002-02-25 |
| Camera, Still, Endoscopic | FXM | Class 1 | General, Plastic Surgery | No | 2011-12-30 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Mediastinoscope, Surgical | EWY | Class 2 | Ear, Nose, Throat | No | 2011-06-14 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2024-03-11 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 1998-03-24 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2024-06-04 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 1986-05-09 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2011-06-14 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2010-03-30 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1998-10-15 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1998-03-24 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 1999-01-26 |
| Lithotriptor, Ultrasonic | FEO | Class 2 | Gastroenterology, Urology | No | 2016-09-19 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 1998-03-11 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2009-12-21 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2009-12-21 |
| Trocar, Tracheal | KCI | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Tonsillectome | KCA | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Speculum, Illuminated | FXF | Class 1 | General, Plastic Surgery | No | 2016-03-01 |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2016-08-23 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2013-10-24 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-10-24 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2001-02-22 |
| Cystometer, Electrical Recording | EXQ | Class 2 | Gastroenterology, Urology | No | 1978-03-31 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 1998-02-04 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 1978-03-31 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 1978-03-31 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 1978-03-31 |
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | Class 2 | Gastroenterology, Urology | No | 2012-11-20 |
| Bougie, Esophageal, Ent | KCD | Class 1 | Ear, Nose, Throat | No | 1998-10-15 |
| Scissors, Wire Cutting, Ent, Sterile | JYA | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-04-21 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2016-09-19 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2001-08-24 |
| Forceps, Wire Closure, Ent, Sterile | JXX | Class 1 | Ear, Nose, Throat | No | 2001-08-24 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2022-08-04 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2013-12-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1978-03-31 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2018-05-22 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2001-08-24 |
Proprietary Names
LOGIC 4K Camera Controller 5525301 and LOGIC 4K Camera Head 85525942
HF Surgery Generator 400KHz
Headlamp 45260
86xxxxx 8517xx
System Green
68601, 68602, AND 68603
Eragon Stitch
D Camera Controller
RIWO D-URS
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device