NKX

Needle, Phacoemulsification, Reprocessed

Product code

NKX

Device name

Needle, Phacoemulsification, Reprocessed

Device class

Class 2

21 CFR

21 CFR 886.4670

Medical specialty

Ophthalmic

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

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).

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