Data / Medical devices / Turkey / Rigicon AS
Rigicon AS: FDA-registered device maker in Bakirkoy Istanbul, Turkey, 1 510(k) clearance
Rigicon AS is registered with the FDA (registration 3013960851) in Bakirkoy Istanbul, Turkey. It lists 7 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
- 3013960851
- Address
- Yesilkoy SB Mah. K Blok No:6, Bakirkoy Istanbul, Turkey, 34149
- Owner or operator
- Rigicon AS (10055846)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- October 12, 2017
- Registered through
- 2026
- Brand names listed
- RIGICON DILATOM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Penile Implant Surgical Accessories | QGA | 1 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Penile | FAE | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Penis, Inflatable | JCW | 3 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Testicular | FAF | 3 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Urethral Sphincter | FAG | 3 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Contract manufacturer, Contract sterilizer, Manufacturer | 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 Penile Implant Surgical Accessories
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
- All makers of Prosthesis, Penis, Inflatable
- All makers of Prosthesis, Penile
- All makers of Prosthesis, Testicular
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.