FDA Registration
Active
🇺🇸 United States
Endomat Select
Reg #: 2020550
·
FEI: 2020550
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- Registration Number
- 2020550
- FEI Number
- 2020550
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 28 Millbury Street
- City
- Auburn
- State
- MA
- ZIP
- 01501
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201355
Owner / Operator
- Firm Name
- KARL STORZ SE & CO KG
- Operator Number
- 8010119
- Address
- Dr.-Karl-Storz-Strasse 34,
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2020-08-03 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2020-08-03 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2020-08-03 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2020-08-03 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2020-08-03 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2020-08-03 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2020-08-03 |
Proprietary Names
Endomat Select
Establishment Types
Repack or Relabel Medical Device