FDA Registration
Active
🇺🇸 United States
ENDOFLATOR 40&50
Reg #: 3010202439
·
FEI: 3007475226
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Karl Storz Endoscopy-America, Inc.
- Registration Number
- 3010202439
- FEI Number
- 3007475226
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2151 E. Grand Avenue
- City
- El Segundo
- State
- CA
- ZIP
- 90245
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161554
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 |
|---|---|---|---|---|---|
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2017-03-06 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2017-03-06 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2017-03-06 |
Proprietary Names
ENDOFLATOR 40&50
Establishment Types
Complaint File Establishment per 21 CFR 820.198