Smith & Nephew Instrument Trays

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K092551 ↗

FDA Product Code

KCT

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Plla, Ha Screw Open recall

  Class II

  FDA 510(k) K080358 Active Cleared 23 Apr 2008

• Smith & Nephew Knotless Instability Anchor

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  FDA 510(k) K093428 Active Cleared 17 Dec 2009

• Biosure Sync Tibial Fixation Device, 6mm, 8mm, 10mm, 12mm

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  FDA 510(k) K093943 Active Cleared 5 Mar 2010

• REGENETEN™ Bioinductive Implant

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  FDA 510(k) K242631 Active Cleared 26 Nov 2024

• Smith & Nephew Mis Instruments

  Class II

  FDA 510(k) K970949 Active Cleared 23 Apr 1997

• Smith & Nephew Instrument Trays

  Class II

  FDA 510(k) K073551 Active Cleared 21 May 2008

See all devices from Smith & Nephew Endoscopy, Inc. →

• Are these instrument trays designed for single-use or can they be reused in a clinical setting?

  These trays are explicitly designed for reuse in clinical settings. They are made of stainless steel and are intended to be sterilized repeatedly using prevacuum steam or high-temperature gravity steam methods, ensuring they remain safe for ongoing use in hospitals.

• What sterilization methods are compatible with these instrument trays, and why?

  The trays are engineered specifically for prevacuum steam sterilization and high-temperature gravity steam sterilization. This design ensures that all contents inside receive optimal exposure to the sterilant, maintaining efficacy and preventing contamination during the sterilization cycle.

• How are these trays regulated, and what does that mean for their use in hospitals?

  These trays are regulated under the FDA’s 510(k) clearance process (K092551) and are classified under product code KCT for surgical instrument trays. The clearance confirms they meet FDA standards for reusable medical devices intended for hospital use, as reviewed by the General Hospital Advisory Committee.

• Are these trays suitable for organizing and transporting instruments in any clinical environment, or are they limited to specific settings?

  While the trays are intended for hospital use, their design—reusable stainless steel with steam sterilization compatibility—makes them suitable for any clinical setting where organized storage and transport of reusable surgical instruments are required, such as operating rooms, endoscopy suites, or procedure rooms.