# K946176: Storz Phacoemulsification Needles

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Feb 14, 1995 after 57 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971439: Storz Microflow and Storz Standard Phacoemulsification Needles (1997), 0 descendants of its own

## Recalls of this device
- Jan 8, 2010 · Not classified · Z-1724-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1723-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate

Source page: https://510kreport.com/device/K946176
Methodology: https://510kreport.com/methodology