FDA Registration
Active
🇺🇸 United States
BOUGIES and Dilators
Reg #: 2020550
·
FEI: 2020550
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K950125
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 |
|---|---|---|---|---|---|
| Dilator, Urethral, Mechanical | FAH | Class 2 | Gastroenterology, Urology | No | 2007-11-20 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2007-11-20 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2007-11-20 |
| Dilator, Catheter, Ureteral | EZN | Class 2 | Gastroenterology, Urology | No | 2007-11-20 |
Proprietary Names
BOUGIES and Dilators
Establishment Types
Repack or Relabel Medical Device