# K203492: Instrument tray, for semi-rigid ureteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Sep 15, 2021 after 300 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171692: Instrument basket, for EndoEYE, Olympus Winter & Ibe GmbH (2018) Summary page 5.

## Indications for use
The instrument tray is intended to be used to enclose and protect one Olympus semi-rigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam sterilizer using the following parameters or cycles: Prevacuum steam sterilization - Exposure time at a temperature of 132 °C (269.6 °F:) Wrapped instruments ....................................4 min. Unwrapped non-porous instruments .............3 min. - Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments ....................................3 min. Unwrapped non-porous instruments ............3 min. - Drying time................................................30 min. After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time..........................................30 min. The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes. The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap. Worst case load: The instrument tray containing a ureteroscope, attachments, light-guide cable, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.

Source page: https://510kreport.com/device/K203492
Methodology: https://510kreport.com/methodology