# K120474: Gyrus Acmi Telescope Storage-Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jul 10, 2012 after 145 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.

## Indications for use
The Gymus AGMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and protect Gyrus ACKII telescopes during Steam Sterilization using the following parameters: STEAM Sterilization Parameters: PreVacuum Temp: 275 0 F 132 0 C Pressure 26psigs; Exposure 3 minutes Dry Time 20 minutes The trays are to be double wrapped with an FDA cleared sterilization wrap. The trays are optional accessories to the Gymos AGMI telescopes. Telescopes without lumens up to 31 cm in length may be sterilized in the tray with a diameter between 2.7mm to 4mm. Two telescopes can be sterilized at one time. Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the sterilization wrap and follow manufacturers recommended storage conditions and timeframes for shelf life.

Source page: https://510kreport.com/device/K120474
Methodology: https://510kreport.com/methodology