OKZ — Endometrial Sampling Kit Class II
FDA product code OKZ covers "Endometrial Sampling Kit", a Class II medical device regulated under 21 CFR 884.1175. Submissions are reviewed by the Obstetrics/Gynecology panel.
Classification Details
- Product Code
- OKZ
- Device Class
- Class II
- Regulation Number
- 884.1175
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- 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.