Ear Irrigation Kit
The Ear Irrigation Kit is a convenience kit containing components used to irrigate the ear canal, commonly for the removal of cerumen (earwax) or foreign material. Classified as FDA Class 1 under regulation 21 CFR 880.6960 within the General Hospital medical specialty, it is subject only to general controls and falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, exempting it from 510(k) requirements when all criteria are satisfied. The product code is OGQ. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGQ
- Device Class
- FDA class 1
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Review Panel
- EN
- Submission Type
- 7
Device Characteristics
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
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.