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510(k) K080558

STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS by Case Medical, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2008
Date Received
February 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Case Medical, Inc.

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  • 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)
  • 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 FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)