# K964743: Storz E8010 Ergotec/Premiere Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Feb 3, 1997 after 69 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- 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 K961310 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K960061: Storz D7108 Microscissors Handpiece/Storz D7106 Microscissors Drive Tube, Storz Instrument Co. (1996) Summary page 1.

## Indications for use
The Storz E8010 ErgoTec™/Premiere® Adaptor is a new device accessory designed to adapt the Storz ErgoTec™ Vitreoretinal Instrument Tips to the Storz D7108 Microscissors Handpiece for general use in posterior segment vitreoretinal ophthalmic surgery.

Source page: https://510kreport.com/device/K964743
Methodology: https://510kreport.com/methodology