FDE · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500
Classification
FDA Product Code
FDE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 876.1500
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
7
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.