Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252307

    Validate with FDA (Live)

    Date Cleared
    2026-01-22

    (182 days)

    Product Code
    Regulation Number
    880.6880
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Getinge GSS67N Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The GSS67N Series Steam Sterilizer is available in 3 models differentiated by chamber length: GSS67N Model 6710 (39 inch chamber), GSS67N Model 6713 (51 inch chamber) and GSS67N Model 6717 (67 inch chamber).

    Device Description

    The Getinge GSS67N Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. There are three model designations to identify three different chamber lengths. The model 6710 is 1000 mm (39") long, model 6713 is 1300 mm (51") long and model 6717 is 1700 mm (67") long.

    The Getinge GSS67N Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1