NLY — Microdebrider, Ent, High Speed, Single Use, Reprocessed Class I
FDA product code NLY covers "Microdebrider, Ent, High Speed, Single Use, Reprocessed", a Class I medical device regulated under 21 CFR 874.4140. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NLY
- Device Class
- Class I
- Regulation Number
- 874.4140
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.)
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142022 | medline renewal | MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES | December 19, 2014 |