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

    JARIT SURGICAL INSTRUMENTS

    K Number: K931959 · Decision Oct 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    11
    Review Days
    167

    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
    JARIT SURGICAL INSTRUMENTS
    K Number
    K931959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J. Jamner Surgical Instruments, Inc.
    Date Received
    April 21, 1993
    Decision Date
    October 5, 1993
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    Similar 510(k) Clearances

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

    Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

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

    CoolSeal Generator® (CSL-200-90)

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

    NEUROMARK System (NMK00301)

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

    LAP-iX2N

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

    OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

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

    MILAN System

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

    Other Clearances by J. Jamner Surgical Instruments, Inc.

    K Number Device Name
    K082349 JARIT HULKA UTERINE TENACULUM FORCEPS
    K944670 JARIT RECOMMENDED SINUS INSTRUMENTS
    K944870 JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680
    K941565 JARIT RECOMMENDED SINUS INSTRUMENTS
    K932456 JARIT SURGICAL INSTRUMENTS
    K933728 JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339
    K931928 JARIT SURGICAL INSTRUMENTS
    K931878 JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680
    K771625 LEININGEO AORTIC PUNCH #310-395 & 397
    K771624 COPE LUNG FORCEPS #305-218
    Search all 11 clearances from J. Jamner Surgical Instruments, Inc. →