OKE — Port Introducer Kit Class II
FDA product code OKE covers "Port Introducer Kit", a Class II medical device regulated under 21 CFR 880.5965. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- OKE
- Device Class
- Class II
- Regulation Number
- 880.5965
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- 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.