NKX · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.4670
Classification
FDA Product Code
NKX
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 886.4670
Review panel
OP
Medical specialty
Ophthalmic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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).