QGA — Penile Implant Surgical Accessories Class I
FDA product code QGA covers "Penile Implant Surgical Accessories", a Class I medical device regulated under 21 CFR 876.3500. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- QGA
- Device Class
- Class I
- Regulation Number
- 876.3500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.