Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4670](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4670) → NKX — Needle, Phacoemulsification, Reprocessed

# NKX · Needle, Phacoemulsification, Reprocessed

_Ophthalmic · 21 CFR 886.4670 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NKX

## Overview

- **Product Code:** NKX
- **Device Name:** Needle, Phacoemulsification, Reprocessed
- **Regulation:** [21 CFR 886.4670](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4670)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **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](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NKX/K060648.md) | REPROCESSED PHACOEMULSIFICATION TIPS | Alliance Medical Corp. | Mar 19, 2007 | SESE |
| [K050518](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NKX/K050518.md) | REPROCESSED PHACOEMUISIFICATION TIPS | Alliance Medical, Inc. | Sep 23, 2005 | SESE |
| [K030179](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NKX/K030179.md) | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES | Surgical Instruments Service and Savings, Inc. | Jan 24, 2003 | SESE |
| [K012698](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NKX/K012698.md) | VANGUARD REPROCESSED PHACOEMULSIFICATION | Vanguard Medical Concepts, Inc. | Nov 9, 2001 | SESE |
| [K012579](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NKX/K012579.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NKX](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NKX)

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