NKZ — Endoilluminator, Reprocessed Class II
FDA product code NKZ covers "Endoilluminator, Reprocessed", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- NKZ
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Used intraocularly to provide light into the posterior of the eye during retinal surgery. Same as product code MPA, except this one is reprocessed. 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).