NKZ

Endoilluminator, Reprocessed

Product code

NKZ

Device name

Endoilluminator, Reprocessed

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).