# K961310: Storz  Premiere II Microsurgical System (CX Series)

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Jun 27, 1996 after 84 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
78 later devices descend from it; 11 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Storz PREMIERE® Microsurgical System: named in the summary without a submission number
- (no number) Alcon Series 20000® Legacy™ Microsurgical System: named in the summary without a submission number
- (no number) SITE TXR™ System: named in the summary without a submission number
- (no number) Chiron CATALYST™ Microsurgical System: named in the summary without a submission number
- (no number) Storz DP8020 Phaco and DP7020 Frag Handpieces: named in the summary without a submission number
- (no number) Grieshaber MPC and PSS Microscissors: named in the summary without a submission number
- (no number) Storz ErgoTec™ Vitreoretinal Instrument System: named in the summary without a submission number
- (no number) Storz DP4800 Posterior Vitrectomy Pack: named in the summary without a submission number
- (no number) Storz DP4310 Deluxe Phaco Pack: named in the summary without a submission number
- (no number) Storz DP9404 Bipolar Adaptor: named in the summary without a submission number
- (no number) Storz D8204 Reusable Bipolar Cable: named in the summary without a submission number
- (no number) Storz S2070 C Disposable Bipolar Cable: named in the summary without a submission number

## Most influential descendants
- K021566: Infiniti (2002), 50 descendants of its own
- K063583: Alcon Vision System (2008), 36 descendants of its own
- K060366: The Amo Ophthalmic Surgical System (2006), 32 descendants of its own
- K063331: Bausch & Lomb NGX Microsurgical System (2006), 24 descendants of its own
- K082845: Infiniti Vision System with Ozil IP (2009), 22 descendants of its own

## Recalls of this device
- Jan 15, 2010 · Not classified · Z-1663-2010: The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.

## Indications for use
The Storz PREMIERE II is a modular ophthalmic microsurgical system which is designed to be configured by Storz for use in anterior segment surgery only, posterior segment surgery only, or both.

Source page: https://510kreport.com/device/K961310
Methodology: https://510kreport.com/methodology