NKX · Needle, Phacoemulsification, Reprocessed
Ophthalmic · 21 CFR 886.4670 · Class 2
Overview
| Product Code | NKX |
|---|---|
| Device Name | Needle, Phacoemulsification, Reprocessed |
| Regulation | 21 CFR 886.4670 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
Classification Rationale
Class II.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060648 | REPROCESSED PHACOEMULSIFICATION TIPS | Alliance Medical Corp. | Mar 19, 2007 | SESE |
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Alliance Medical, Inc. | Sep 23, 2005 | SESE |
| K030179 | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES | Surgical Instruments Service and Savings, Inc. | Jan 24, 2003 | SESE |
| K012698 | VANGUARD REPROCESSED PHACOEMULSIFICATION | Vanguard Medical Concepts, Inc. | Nov 9, 2001 | SESE |
| K012579 | REPROCESSED PHACO TIPS | Sterilmed, Inc. | Nov 8, 2001 | SESE |
Top Applicants
- Vanguard Medical Concepts, Inc. — 1 clearance
- Surgical Instruments Service and Savings, Inc. — 1 clearance
- Sterilmed, Inc. — 1 clearance
- Alliance Medical, Inc. — 1 clearance
- Alliance Medical Corp. — 1 clearance
