OGS — Myringotomy Procedure Kit Class II
FDA product code OGS covers "Myringotomy Procedure Kit", a Class II medical device regulated under 21 CFR 874.3880. Submissions are reviewed by the Ear, Nose, Throat panel.
Classification Details
- Product Code
- OGS
- Device Class
- Class II
- Regulation Number
- 874.3880
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- 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.