FCD — Barium Enema Kit Class I
FDA product code FCD covers "Barium Enema Kit", a Class I medical device regulated under 21 CFR 876.5210. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCD
- Device Class
- Class I
- Regulation Number
- 876.5210
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.