FDA Product Code KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Maintaining sterility of surgical instruments between sterilization and use is as important as the sterilization process itself. FDA product code KCT covers sterilization wrap containers, trays, and cassettes.
These rigid or semi-rigid systems protect sterilized instruments from contamination during storage and transport to the point of use. Unlike sterilization wraps, rigid containers provide a durable, reusable barrier that maintains sterility for extended periods.
KCT devices are Class II medical devices, regulated under 21 CFR 880.6850 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Dentsply Sirona, Inc., KARL STORZ Endoscopy-America, Inc. and Jjgc Industria E Comercio DE Materiais Dentarios S.A..
List of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Sterilization Wrap Containers, Trays, Cassettes & Other Accessories devices (product code KCT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →