BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CRYOGEN CARDIAC CRYOSURGICAL SYSTEM

    K Number: K974320 · Decision Feb 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    4
    Review Days
    78

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
    K Number
    K974320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryogen, Inc.
    Date Received
    November 17, 1997
    Decision Date
    February 3, 1998
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OCL), ordered by most recent decision date.

    Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Isolator Synergy EnCapture Ablation System (EMH)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AtriCure Isolator® Synergy™ Surgical Ablation System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Cryogen, Inc.

    K Number Device Name
    K003050 CRYOSURGICAL UNIT AND ACCESSORIES
    K972662 CRYOGEN CRYOSURGICAL SYSTEM
    K964971 CRYOGEN CRYOSURGICAL SYSTEM