# K022833: Benjamin Envoy Phaco Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Benjamin Biomedical, Inc.
- Decided: Sep 9, 2002 after 14 days
- Product code: HQC (Unit, Phacofragmentation)
- 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
Longest line of descent: 1 generation back to K946227 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946227: Storz Premiere (R) Microsurgical System, Storz Instrument Co. (1995) Summary page 1.

## Indications for use
As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.

Source page: https://510kreport.com/device/K022833
Methodology: https://510kreport.com/methodology