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Needle, Phacoemulsification, Reprocessed

FDA product code NKX · 5 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 886.4670
Review panel
OP
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2001-11-08 – 2007-03-19

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).

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