NKX — Needle, Phacoemulsification, Reprocessed Class II
Classification Details
- Product Code
- NKX
- Device Class
- Class II
- Regulation Number
- 886.4670
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K060648 | alliance medical | REPROCESSED PHACOEMULSIFICATION TIPS | March 19, 2007 |
| K050518 | alliance medical | REPROCESSED PHACOEMUISIFICATION TIPS | September 23, 2005 |
| K030179 | surgical instruments service and savings | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES | January 24, 2003 |
| K012698 | vanguard medical concepts | VANGUARD REPROCESSED PHACOEMULSIFICATION | November 9, 2001 |
| K012579 | sterilmed | REPROCESSED PHACO TIPS | November 8, 2001 |