# K954340: Storz Microflow Phacoemulsification Needle

- Pathway: 510(k) (Traditional)
- Applicant: Storz
- Decided: Dec 14, 1995 after 87 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 5 (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-1725-2010: 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-1726-2010: 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-1730-2010: 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-1727-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Aug 25, 2003 · Not classified · Z-1279-03: The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.

Source page: https://510kreport.com/device/K954340
Methodology: https://510kreport.com/methodology