DeviceClearance

Product code NKX— Ophthalmic

MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES

Classification name
Needle, Phacoemulsification, Reprocessed
Device class
Class 2
Regulation
21 CFR 886.4670
Advisory panel
Ophthalmic
Total cleared
5
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code NKX under 21 CFR 886.4670, via openFDA

Market context for product code NKX

FDA has cleared 5 devices under product code NKX between 2001 and 2007, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NKX

Recent clearances under product code NKX

Data sourced from openFDA. This site is unofficial and independent of the FDA.