FCDClass I
Barium Enema Kit
21 CFR 876.5210 / Gastroenterology, Urology
FCD is the FDA product code for Barium Enema Kit, a class I device type, regulated under 21 CFR 876.5210. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FCD
- Device name
- Barium Enema Kit
- FDA 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.
- Regulation
- 21 CFR 876.5210
- Device class
- Class I
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code FCD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1993 | 1 |
Applicants with the most clearances
Product code FCD| Applicant | Clearances |
|---|---|
| Eisai U.S.A., Inc. | 1 |
| Lafayette Pharmaceuticals, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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