NLZ — Bur, Ent, Diamond Coated, Single Use, Reprocessed Class I
FDA product code NLZ covers "Bur, Ent, Diamond Coated, Single Use, Reprocessed", a Class I medical device regulated under 21 CFR 874.4140. Submissions are reviewed by the Ear, Nose, Throat panel.
Classification Details
- Product Code
- NLZ
- Device Class
- Class I
- Regulation Number
- 874.4140
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).