# K972664: Storz Millennium Viscous Fluid System

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Oct 10, 1997 after 86 days
- Product code: MRH (Pump, Infusion, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K902835 (1990). 3 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961310: Storz  Premiere II Microsurgical System (CX Series), Storz Instrument Co. (1996) Summary page 1.
- K963434: Viscous Fluid System, Escalon Trek Medical (1996) Summary page 1.
- K902835: FTS-100 Fluid Transfer System, Richard James, Inc. (1990) Summary page 1.
- (no number) Alcon Accurus™ Vitreoretinal Surgical System: named in the summary without a submission number

## Most influential descendants
- K993039: Viscous Fluid Injector System Module (CX5700) (2000), 13 descendants of its own
- K050716: Iscience Surgical Viscoinjector (2005), 11 descendants of its own
- K132494: Viscoelastic Injector (2013), 10 descendants of its own
- K143205: Viscoelastic Injector (2014), 9 descendants of its own
- K171905: VISCO 360 Viscosurgical System (2017), 8 descendants of its own

## Indications for use
The Storz Millennium™ Viscous Fluid System is a new device intended for the injection and aspiration of viscous fluids into and out of the eye during ophthalmic posterior vitreoretinal surgery. The Storz viscous fluid system consists of the Storz CX5700 module to be used with the Storz Millennium™ Microsurgical System and the Storz CX5710 sterile single use accessory pack.

Source page: https://510kreport.com/device/K972664
Methodology: https://510kreport.com/methodology