QGC — Suprapubic Catheter Accessories Class I
FDA product code QGC covers "Suprapubic Catheter Accessories", a Class I medical device regulated under 21 CFR 876.5100. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- QGC
- Device Class
- Class I
- Regulation Number
- 876.5100
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.