Barium Enema Kit
The Barium Enema Kit (product code FCD) is a convenience kit that contains the components necessary to administer a barium enema for radiological examination of the lower gastrointestinal tract. It is an FDA Class 1 device (lowest risk), established under the May 20, 1997 Convenience Kits Interim Regulatory Guidance; kits meeting all criteria in that guidance are under enforcement discretion and do not require a 510(k). It is regulated under 21 CFR 876.5210 in the Gastroenterology and Urology specialty. No special flags apply.
Basic Information
- Product Code
- FCD
- Device Class
- FDA class 1
- Regulation Number
- 876.5210
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.