# K012698: Vanguard Reprocessed Phacoemulsification

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Nov 9, 2001 after 87 days
- Product code: NKX (Needle, Phacoemulsification, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alcon Laboratories Microtip™ and TurboSonics® Phacoemulsification Needles/Tips: named in the summary without a submission number
- (no number) Allergan AMO® Proficient® Phacoemulsification Needles/Tips: named in the summary without a submission number

## Indications for use
As an accessory device of a compatible phacoemulsification system, the phaco needle is intended for the breaking up of a cataractous lens nucleus with simultaneous irrigation and aspiration of the emulsified fragments.

Source page: https://510kreport.com/device/K012698
Methodology: https://510kreport.com/methodology