OGU — Pierced Ear/Entry Cleaning Tray Class I
FDA product code OGU covers "Pierced Ear/Entry Cleaning Tray", a Class I medical device regulated under 21 CFR 874.4420. Submissions are reviewed by the Ear, Nose, Throat panel.
Classification Details
- Product Code
- OGU
- Device Class
- Class I
- Regulation Number
- 874.4420
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
Contents typically includes: Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.