Home / 510(k) Clearances / K221492

510(k) K221492

SteriTite Container System with MediTray Parts by Case Medical, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
May 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Case Medical, Inc.

  • K240898 — SteriTite rigid reusable sterilization container with MediTray Products (July 31, 2024)
  • K212711 — SteriTite Container System with MediTray Products (April 29, 2022)
  • K173259 — Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTr (June 13, 2018)
  • K161415 — SteriTite Containers System & MediTray Products (February 10, 2017)
  • K112904 — STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS (January 24, 2012)
  • K110682 — STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS (July 1, 2011)
  • K090068 — STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS (February 24, 2010)
  • K080558 — STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS (December 5, 2008)
  • K022978 — STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS (May 9, 2003)
  • K023614 — STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM (April 7, 2003)

Other clearances for product code KCT

  • K253791 — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula Syste (February 26, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K251756 — Sterilization Trays (November 14, 2025)
  • K243425 — Guided DAS Surgical Kit (July 22, 2025)
  • K251300 — Plastic Surgical Kits (July 22, 2025)
  • K243589 — PAL Sterilization Case (June 20, 2025)
  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K250029 — ONE TRAY® Sealed Sterilization Container System (May 1, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)