Home / 510(k) Clearances / K153554

510(k) K153554

Genesis Low Temperature Reusable Rigid Container System by Carefusion 2200, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2016
Date Received
December 14, 2015
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 Carefusion 2200, Inc.

  • K210324 — V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV (March 4, 2021)
  • K163615 — Snowden-Pencer MicroLap 3mm Laparoscopic Instruments (May 4, 2017)
  • K162432 — Multi-Link X2 ECG Cable and Lead Wire System (January 18, 2017)
  • K160764 — AirLife Autofill Humidification Chamber (August 25, 2016)
  • K151036 — Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instrum (February 1, 2016)
  • K142529 — Genesis Reusable Rigid Container System (January 8, 2015)
  • K140850 — GENESIS REUSABLE RIGID CONTAINER SYSTEM (August 27, 2014)
  • K140761 — KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (April 21, 2014)
  • K113407 — SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS (September 7, 2012)
  • K112535 — GENESIS REUSABLE RIGID CONTAINER SYSTEM (April 27, 2012)

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)