Genesis Sterrad Compatible Reusable Sterilization Container System

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

510(k) Number

K012931 ↗

FDA Product Code

FRG

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K022765 Active Cleared 11 Oct 2002

• Powder Free Sterile Latex Examination Gloves

  Class I

  FDA 510(k) K001141 Active Cleared 9 May 2000

• Sterile Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K010211 Active Cleared 15 Feb 2001

• Ultraderm Sterile Latex Powdered Surgical Sloves with Protein Content Labeling Claim (50 Micrograms or Less)

  Class I

  FDA 510(k) K991205 Active Cleared 13 Oct 1999

• Convertors Drape Material

  Class II

  FDA 510(k) K964125 Active Cleared 23 Dec 1996

• Convertors Impervious Shoe Covers

  Class I

  FDA 510(k) K970815 Active Cleared 27 Mar 1997

See all devices from Allegiance Healthcare Corp. →

• What is the Genesis Sterrad-Compatible Reusable Sterilization Container System used for?

  This system is designed to house and protect medical instruments during hydrogen peroxide-based Sterrad sterilization cycles. It ensures proper containment and maintains instrument integrity while preserving sterility, making it ideal for clinical environments like hospitals and surgical centers.

• How is the Genesis system supplied, and what types of configurations are available?

  The system is supplied as a reusable medical device. It includes multiple container designs and sizes, along with various inner basket and platform configurations to accommodate different instrument shapes and sizes, ensuring flexibility for diverse clinical workflows.

• Is the Genesis Sterrad-Compatible Reusable Sterilization Container System single-use or reusable?

  The system is explicitly designed for reuse, supporting sustainable and cost-effective sterilization practices in healthcare settings. Proper storage and handling between uses are required to maintain sterility and functionality.

• What storage and handling protocols should be followed for this device?

  The Genesis system follows standard reusable medical device protocols for storage and handling. This includes maintaining cleanliness, preventing contamination, and ensuring proper drying between uses to preserve sterility and device integrity.

• What regulatory clearance does this device hold?

  The Genesis Sterrad-Compatible Reusable Sterilization Container System holds FDA 510(k) clearance under the reference number K012931, classified under product code FRG. This clearance confirms its substantial equivalence to a predicate device for use in clinical settings.