# K121904: Gynecology Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Division
- Decided: Mar 11, 2013 after 255 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090562: Smith & Nephew Instrument Trays, Smith & Nephew, Inc. (2009) Summary page 2.

## Indications for use
The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instrumentation for convenient organized storage, sterilization and tansport between usages. The instrument tray must be doubled wrapped with an FDA cleared polypropylene sterilization wrap. The instrument wrap is suitable for use in pre-vacuum steam sterilization method. The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Maintenance of sterility is dependent on the sterilization wrap shelf life and not the tray. Users must follow the instructions for use supplied with the sterilization wrap and follow the manufacturer's recommended storage conditions and time flames for shelf life. The maximum number of devices that could be processed in one load is five. The maximum weight load is 8.4lbs.

Source page: https://510kreport.com/device/K121904
Methodology: https://510kreport.com/methodology