Rigi10 Malleable Penile Prosthesis
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- RIGI10 EUDAMEDFDA UDI
- Generic Name
- Rigid penile prosthesis FDA UDI
- Device Name
- Rigi10™ Malleable Penile Prosthesis EUDAMEDDIAMETER:10MM MALLEABLE PENILE PROSTHESIS FDA UDIDIAMETER:13MM MALLEABLE PENILE PROSTHESIS FDA UDIDIAMETER:9MM MALLEABLE PENILE PROSTHESIS FDA UDI
- Model / Reference
- Dia: 13 mm EUDAMEDRG1013H EUDAMEDDia: 9 mm EUDAMEDRG1009H EUDAMEDDia: 11 mm EUDAMEDRG1011H EUDAMEDDia: 14 mm EUDAMEDRG1014H EUDAMEDRG1010 FDA UDIRG1013 FDA UDIRG1009 FDA UDI
- Description
- DIAMETER:10MM MALLEABLE PENILE PROSTHESIS FDA UDIDIAMETER:13MM MALLEABLE PENILE PROSTHESIS FDA UDIDIAMETER:9MM MALLEABLE PENILE PROSTHESIS FDA UDI
Identifiers
- Catalog Number
- RG1010 FDA UDIRG1013 FDA UDIRG1009 FDA UDI
- Primary DI / UDI-DI
- 00850299008467 EUDAMEDFDA UDI00850299008481 EUDAMEDFDA UDI00850299008443 EUDAMEDFDA UDI00850299008498 EUDAMED
- Basic UDI-DI
- B-00850299008481 EUDAMEDB-00850299008443 EUDAMEDB-00850299008467 EUDAMEDB-00850299008498 EUDAMED
- 510(k) Number
- K181673 FDA 510(k)
- FDA Product Code
- FAE FDA 510(k)FDA UDI
- EMDN Code
- P080202 PENILE PROSTHESES EUDAMED
- GMDN Term
- Rigid penile prosthesis FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.3630 FDA 510(k)
- Regulation Number
- 876.3630 FDA 510(k)FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDIOuter Diameter — 13 Millimeter FDA UDIOuter Diameter — 9 Millimeter FDA UDI
The Rigi10 Malleable Penile Prosthesis is a medical device classified as a penile prosthesis, designed to provide structural support and malleability for erectile dysfunction treatment. It consists of inflatable or non-inflatable components intended for surgical implantation to facilitate penile rigidity and natural curvature during erection.
This device is supplied sterile and intended for single-use implantation by a qualified surgeon in an operating room setting. It is regulated under FDA 510(k) clearance, MDD, and MDR, with a classification of Class II. Multiple reference codes (e.g., 3013960851, 3002618605) identify its regulatory and registration status, and it is intended for use in urological procedures.
Frequently asked questions
What is the primary purpose of the Rigi10 Malleable Penile Prosthesis and how does it differ from inflatable models?
The Rigi10 Malleable Penile Prosthesis is designed to provide structural support and malleability for patients with erectile dysfunction, allowing natural penile curvature during erection. Unlike inflatable prostheses, it does not require fluid inflation—it relies on its rigid yet flexible construction to maintain rigidity when bent into position, offering a simpler mechanism for achieving penile rigidity post-implantation.
Is the Rigi10 Malleable Penile Prosthesis intended for reuse or single-use, and how should it be handled before surgery?
The device is explicitly intended for single-use implantation and is supplied sterile. It must be handled in a sterile field by a qualified surgeon during an operating room procedure, as it is not designed for reuse or reprocessing. Sterility is maintained until surgical implantation.
What regulatory pathways does the Rigi10 Malleable Penile Prosthesis follow, and which committees reviewed its submission?
The device follows FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) pathways. Its submission was reviewed by the Urology (GU) Advisory Committee, with a decision classified as *Substantially Equivalent* (SESE) under the abbreviated clearance type. The regulatory classification is Class II, and it is categorized under product code FAE for penile prostheses.
Are there multiple sizes or models available for the Rigi10 Malleable Penile Prosthesis, and how are they identified?
While the provided data does not specify exact sizing details, the device is listed under multiple FEI numbers (e.g., 3013960851, 3002618605), which may correspond to different configurations or sizes. These identifiers are used for regulatory tracking and registration, not clinical sizing. A surgeon would select the appropriate model based on patient anatomy during preoperative planning.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181673 | Class II | Active |
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Manufacturer
- Manufacturer
- Rigicon, Inc.
Sources (8)
- FDA 510(k) K181673 24 fields · synced Sep 18, 2026
- FDA UDI 4c8995b7-e00f-47f0-ac08-f367abce8b1e 37 fields · synced May 30, 2026
- FDA UDI 8d77f8bb-ca2a-4336-aeaf-da10517032a6 37 fields · synced May 30, 2026
- FDA UDI f23c8afb-a66f-4c4d-848f-81d3bd6f399c 37 fields · synced May 30, 2026
- EUDAMED 4d30a120-b7f3-4513-babe-784be18fff38 61 fields · synced Jul 14, 2026
- EUDAMED de33e646-55f5-4a3e-a765-766502bcfa28 61 fields · synced Jul 17, 2026
- EUDAMED 2e671a1f-66fa-412f-b9ff-d36b3a90e54b 61 fields · synced Jul 23, 2026
- EUDAMED 7b897f5e-077d-40d6-a1af-170c760ef1a1 61 fields · synced Jul 29, 2026