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

    ENDO-BEND(TM) SHAVER

    K Number: K950054 · Decision Jun 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    14
    Review Days
    174

    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
    ENDO-BEND(TM) SHAVER
    K Number
    K950054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paladin Medical, Inc.
    Date Received
    January 6, 1995
    Decision Date
    June 29, 1995
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

    Similar 510(k) Clearances

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

    Digital ClarusScope System and Digital NeuroPEN System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Freedom DS™ Decompression System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VantageTM Lumbar Decompression Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PUREVUE™ FMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Articulator Arthroscopic Bur

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Paladin Medical, Inc.

    K Number Device Name
    K993306 NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
    K970347 MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
    K971290 STRATASYS FDM MEDMODELER SYSTEM
    K964222 ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
    K935220 CORE PREVENT MATTRESS MODIFICATION
    K921015 SHARPE ENDOSPONGE ASPIIRATOR
    K915743 SHARPE ENDOTENACULUM
    K921888 SHARPE ENDODISSECTOR
    K915747 SHARPE ENDOFORCEPS
    K915744 SHARPE ENDOHEMOSTAT
    Search all 14 clearances from Paladin Medical, Inc. →