FDR — Sphyncteroscope Class II
FDA product code FDR covers "Sphyncteroscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- FDR
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No