Product code NKZ

Device name
Endoilluminator, Reprocessed
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.1500
Review panel
OP
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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).
Source
FDA openFDA device classification dataset