FDA Registration
Active
🇺🇸 United States
DIMEDA
Reg #: 3008720584
·
FEI: 3008720584
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Ovesco Endoscopy USA
- Registration Number
- 3008720584
- FEI Number
- 3008720584
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 15300 Weston Parkway, Suite 101
- City
- Cary
- State
- NC
- ZIP
- 27513
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200684
Owner / Operator
- Firm Name
- Ovesco Endoscopy
- Operator Number
- 10031680
- Address
- 15300 Weston Parkway, Suite 101
- City
- Cary
- State
- NC
- Postal Code
- 27513
- Country
- US
- Correspondent
- Marc O Schurr
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2020-06-04 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2020-06-04 |
| Guillotine, Tonsil | KBO | Class 1 | Ear, Nose, Throat | No | 1994-02-18 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2020-06-04 |
Proprietary Names
DIMEDA
gastroduodenal FTRD Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198