Prosthesis, Penis, Rigid Rod
A rigid rod penile prosthesis is a semi-rigid implantable device surgically inserted into the corpora cavernosa of the penis to provide a permanent erection, used to treat erectile dysfunction that is unresponsive to other therapies. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FTQ, regulated under 21 CFR 876.3630, within the Gastroenterology, Urology medical specialty. This device is designated as an implant.
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Basic Information
- Product Code
- FTQ
- Device Class
- FDA class 2
- Regulation Number
- 876.3630
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.