NKX · Class II · 21 CFR 886.4670

FDA Product Code NKX: Needle, Phacoemulsification, Reprocessed

Needle For Phacoemulsification Device To Remove Cataractous Lens. Same As Needle For Main Phacoemulsification Device And Un-reprocessed Needle With Product Code Hqc, Except This Is A "reprocessed" Needle. The Phacoemulsification Device Is Not Reprocessed, Just The Needle. 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).

5
Total
5
Cleared
152d
Avg days
2001
Since

FDA 510(k) Cleared Needle, Phacoemulsification, Reprocessed Devices (Product Code NKX)

5 devices
1–5 of 5
No devices found for this product code.

About Product Code NKX - Regulatory Context