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

    DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

    K Number: K954989 · Decision Nov 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    22
    Review Days
    27

    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
    DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
    K Number
    K954989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Dyonics, Inc.
    Date Received
    October 31, 1995
    Decision Date
    November 27, 1995
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

    Similar 510(k) Clearances

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

    Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    hekaDrill

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ORiGO System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AMADEO, M-UK1015 (incl. attachments and accessories)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Celeris, Disposable Sinus Debrider

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Smith & Nephew Dyonics, Inc.

    K Number Device Name
    K955914 LIMITED REUSE ARTHROSCOPIC BLADES
    K954627 ECTRA II LIGAMENT RELEASE SYSTEM
    K953695 DYONICS DISPOSABLE ARTHROSCOPIC BLADES
    K953387 ECTRA LIGAMENT RELEASE SYSTEM
    K945182 DYONICS FIXATION SCREWS
    K936071 SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
    K934299 DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
    K920267 DYONICS ARTHROSCOPIC KIT
    K922176 INTELIJET SUCTION SUPPLY
    K914963 SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET
    Search all 22 clearances from Smith & Nephew Dyonics, Inc. →