FDA Registration
Active
🇺🇸 United States
RIGICON, INC.
Reg #: 3013987875
·
FEI: 3013987875
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- RIGICON, INC.
- Registration Number
- 3013987875
- FEI Number
- 3013987875
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2805 Veterans Highway, Suite 5
- City
- Ronkonkoma
- State
- NY
- ZIP
- 11779
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181673
Owner / Operator
- Firm Name
- Rigicon, Inc.
- Operator Number
- 10055847
- Address
- 2805 Veterans Highway, SUITE 5
- City
- Ronkonkoma
- State
- NY
- Postal Code
- 11779
- Country
- US
- Correspondent
- Ahmet M Luleci
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Penile | FAE | Class 2 | Gastroenterology, Urology | No | 2019-05-09 |
| Prosthesis, Urethral Sphincter | FAG | Class 3 | Unknown | No | 2019-08-08 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-06-07 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2020-07-07 |
| Prosthesis, Testicular | FAF | Class 3 | Gastroenterology, Urology | No | 2017-10-12 |
| Prosthesis, Penis, Inflatable | JCW | Class 3 | Gastroenterology, Urology | No | 2019-08-08 |
Proprietary Names
Rigicon Surgical Retractor Kit
Rigicon Furlow Insertion Tool
Rigicon HL Dilator
Testi10 Firm Testicular Prosthesis
Testi 10 Saline-Filled Testicular Proshesis
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device