QGD — Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories Class I
FDA product code QGD covers "Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories", a Class I medical device regulated under 21 CFR 876.5290. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- QGD
- Device Class
- Class I
- Regulation Number
- 876.5290
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing.