# Microdebrider, Ent, High Speed, Single Use, Reprocessed
> **Product code: NLY** · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.4140
## Classification
- **FDA Product Code:** NLY
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 874.4140
- **Review panel:** EN
- **Medical specialty:** Ear, Nose, Throat
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

ENT microdebrider is an accessory to an ENT drill system.  It is intended to remove soft and hard tissue during ear, nost and throat surgery.  These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use ENT microdebrider.)

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NLY)
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