FDA Registration
Active
🇯🇵 Japan
CLV-S400
Reg #: 8010047
·
FEI: 3002807795
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Registration Number
- 8010047
- FEI Number
- 3002807795
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K151011
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
US Agent
- Business Name
- Gyrus ACMI, Inc.
- Contact Name
- Todd Brill
- Address
- 800 West Park Drive, --
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2016-02-18 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-02-18 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2016-02-18 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2016-02-18 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2016-02-18 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2016-02-18 |
Proprietary Names
CLV-S400
OTV-S400
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility