# K980488: Storz Millennium Microsurgicl System High Speed Vitrectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Mar 23, 1998 after 42 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953575 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K961078: Automated Vitrectomy Device, Promex, Inc. (1996) Summary page 1.
- K961738: Vit Commander System, Scieran Technologies, Inc. (1996) Summary page 1.
- K954816: Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic Posterior Vitrectomy Pack with Variable Port Cutter & RX, Storz Instrument Co. (1996) Summary page 1.
- (no number) Alcon Accurus Vitreoretinal Surgical System: named in the summary without a submission number
- (no number) Alcon Accurus InnoVit Probe: named in the summary without a submission number
- (no number) Alcon Accurus Total Plus Pak: named in the summary without a submission number

## Most influential descendants
- K031404: Dignity Ophthalmic Surgical System (2003), 0 descendants of its own

## Recalls of this device
- Feb 9, 2007 · Not classified · Z-0766-2007: The cutter probe tip breaks during use.
- Feb 9, 2007 · Not classified · Z-0765-2007: The cutter probe tip breaks during use.
- Dec 14, 2006 · Not classified · Z-0496-2007: The cutter tip could break during a procedure
- Dec 14, 2006 · Not classified · Z-0495-2007: The cutter tip could break during a procedure

## Indications for use
The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 sterile single use accessory pack.

Source page: https://510kreport.com/device/K980488
Methodology: https://510kreport.com/methodology