FCD · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5210
Classification
FDA Product Code
FCD
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.5210
Review panel
RA
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.