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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: FWZ FDA class 1

    Operating Room Accessories Table Tray

    General, Plastic Surgery

    View full classification →

    An operating room accessories table tray is a convenience kit containing a combination of accessories and components used alongside operating room tables, packaged together for procedural convenience. It is classified as FDA Class 1 (lowest risk), regulated under 21 CFR 878.4950, within the General, Plastic Surgery medical specialty. Per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this type of convenience kit is under enforcement discretion and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RETRACTOR ARM CLAMP
    'LIL MAC ACCESSORY CLAMP(TM)
    CARBON LIGHTS HAND SURGERY TABLE
    KAPS POSITIONING ARM
    WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)
    SPONGE COUNTER
    MIDKIFF GEOSTATIC CLAMP
    LATERAL BUTTRESS SUPPORT
    PREP AND OPERATING STAND
    PARK CITY SHOULDER POSITIONER
    TKO TELESCOPING LITHOTOMY STIRRUP
    LINCOLN MILLS FOOT AND LEG HOLDER
    DECUBITUS CARE PAD
    SECOND ASSISTANT
    LINCOLN MILLS HIP HOLDER
    FREE ARM(TM)
    SPINAL SURGERY FRAME
    WEHBE ARM HOLDER
    VARUS AND VALGUS LEG HOLDER
    ALLEN MALLEABLE ANESTHESIA SCREEN
    THE PORTABLE ORDERLY
    MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY
    MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM
    MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT
    MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT
    MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT
    MCCONNELL ORTHOPEDIC TIBIAL POSITIONER
    MCCONNELL ORTHOPEDIC ANKLE POSITIONER
    MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER
    MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT
    MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM
    MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP)
    MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY
    HAND SURGERY TABLE EXTENSION
    CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION
    LITHOTOMY HOLDERS
    RADIOLUCENT TABLE EXTENSION
    ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER
    COLLINS POSITIONING DEVICE
    ARTHROSCOPIC ANKLE HOLDER
    RAIL CLAMP EXTENSION PIECE
    C ARM SURGICAL TABLE
    BASILDON-GARDNER SPINAL FRAME
    FPP ARMBOARD STRAP
    DEVON HEAD REST
    ULNAR NERVE PROTECTOR
    SHUTT UNIVERSAL STRESS POST
    ELEVATOR CUSHION
    PROTET HOLDERS-BLOCKS & ROLL
    ACUFEX UNIVERSAL LEG HOLDER

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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