FDA Registration
Active
🇺🇸 United States
Biopsy Forceps - enteroscope (00711291) (EN-CFE)
Reg #: 1528319
·
FEI: 1000122656
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- UNITED STATES ENDOSCOPY GROUP, INC.
- Registration Number
- 1528319
- FEI Number
- 1000122656
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5976 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K924106
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2020-10-29 |
Proprietary Names
Biopsy Forceps - enteroscope (00711291) (EN-CFE)
Biopsy Forceps - sheathed (00711205) (EN-CFE)
Biopsy Forceps - pediatric (00711261, 00711262) (EN-CFE)
Biopsy Forceps (00711201, 00711202, 00711203, 00711204) (EN-CFE)
Establishment Types
Complaint File Establishment per 21 CFR 820.198