Data / Medical devices / United States / Rigicon, Inc.
Rigicon, Inc.: FDA-registered device maker in Ronkonkoma, NY, United States, 1 510(k) clearance
Rigicon, Inc. is registered with the FDA (registration 3013987875) in Ronkonkoma, NY, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013987875
- Address
- 2805 Veterans Highway Suite 5, Ronkonkoma, NY, United States, 11779
- Owner or operator
- Rigicon, Inc. (10055847)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- October 12, 2017
- Registered through
- 2026
- Brand names listed
- Rigicon Furlow Insertion Tool, Rigicon HL Dilator, Rigicon Surgical Retractor Kit, Testi 10 Saline-Filled Testicular Proshesis, Testi10 Firm Testicular Prosthesis
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Penile | FAE | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Penis, Inflatable | JCW | 3 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Testicular | FAF | 3 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Urethral Sphincter | FAG | 3 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2019 | K181673 | Rigi10 Malleable Penile Prosthesis | FAE | Substantially Equivalent | Rigicon, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor
- All makers of Prosthesis, Testicular
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
- All makers of Prosthesis, Penile
- All makers of Prosthesis, Penis, Inflatable
Updated April 15, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.