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

    DETACHATIP THORACOSCOPIC SCISSORS

    K Number: K960554 · Decision Mar 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    15
    Review Days
    25

    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
    DETACHATIP THORACOSCOPIC SCISSORS
    K Number
    K960554
    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
    Microsurge, Inc.
    Date Received
    February 9, 1996
    Decision Date
    March 5, 1996
    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 Microsurge, Inc.

    K Number Device Name
    K964109 MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP
    K955408 MICROSURGE THORACOSCOPIC INSTRUMENTS
    K954641 ENDO-LEADER
    K954072 MICROSURGE PUNCTURE CLOSE DEVICE
    K954520 MICROSURGE VERESS NEEDLE
    K953121 MICROSURGE THORACOSCOPIC ACCESS SYSTEM
    K951230 MICROSURGE BIPOLAR GRASPERS
    K933750 MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF
    K930355 MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULAS
    K925830 MICROSURGE SUCTION/IRRIGATION SYSTEM
    Search all 15 clearances from Microsurge, Inc. →