# Myringotomy Procedure Kit
> **Product code: OGS** · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3880
## Classification
- **FDA Product Code:** OGS
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 874.3880
- **Review panel:** EN
- **Medical specialty:** Ear, Nose, Throat
- **Submission type:** 7
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 14
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OGS)
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