# K102970: Gyrus Acmi Cyber Wand-Sterilization Trays Model FGT

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: May 20, 2011 after 226 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K844002 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092682: Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays, Gyrus Acmi, Inc. (2009) Summary page 1.
- K040223: Polyvac Instrument Delivery System, Symmetry Medical USA, Inc. (2004) Summary page 1.

## Indications for use
The Gyrus ACMI CyberWand™ Sterilization Trays are intended to be used to enclose and protect only CyberWand™ transducers and accessories during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand™ transducers and accessories for which they are designed. The trays are indicated for ETO sterilization of only the following (maximum load) per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets, 1 Wrench, 1 Cleaning stylet. EtO Sterilization parameters: EtO Sterilize using 100% ethylene oxide: Temp 55 °C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration 12 hours @55 °C.

Source page: https://510kreport.com/device/K102970
Methodology: https://510kreport.com/methodology