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

    HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME

    K Number: K023487 · Decision Mar 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    30
    Review Days
    154

    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
    HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
    K Number
    K023487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OraSure Technologies, Inc.
    Date Received
    October 17, 2002
    Decision Date
    March 20, 2003
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

    Similar 510(k) Clearances

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

    ERBECRYO 2 Cryosurgical Unit and Accessories

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

    ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe

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

    Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

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

    XSense Cryoablation System with CryoProbes

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

    CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

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

    Dr. Yglo Skin Tag Remover

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

    Other Clearances by OraSure Technologies, Inc.

    K Number Device Name
    DEN190025 OraQuick Ebola Rapid Antigen Test
    K060859 COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
    K013882 OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
    K020371 UPLINK TEST SYSTEM
    K011057 INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
    K002375 STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
    K001976 STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
    K002010 STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
    K000399 STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
    K001197 COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
    Search all 30 clearances from OraSure Technologies, Inc. →