FDA Registration
Active
🇺🇸 United States
72-00258-0 ConMed GS2000
Reg #: 1450997
·
FEI: 1450997
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Northgate Technologies Inc.
- Registration Number
- 1450997
- FEI Number
- 1450997
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1591 Scottsdale Court
- City
- Elgin
- State
- IL
- ZIP
- 60123
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120151
Owner / Operator
- Firm Name
- Northgate Technologies, Inc.
- Operator Number
- 10092614
- Address
- 1591 Scottsdale Court
- City
- Elgin
- State
- IL
- Postal Code
- 60123
- Country
- US
- Correspondent
- Todd Gatto
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2025-01-27 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2025-01-27 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2025-01-27 |
Proprietary Names
72-00258-0 ConMed GS2000
7-650-00 Nebulae I
72-00259-0/72203994 Smith & Nephew 500
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device