OGU · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.4420
Classification
FDA Product Code
OGU
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 874.4420
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
7
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.