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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: HOZ FDA class 2

    Sponge, Ophthalmic

    Ophthalmic

    View full classification →

    An Ophthalmic Sponge is an absorbent device used during eye surgery to control bleeding, remove excess fluid, and keep the surgical field clear, available in various shapes and sizes suited to delicate intraocular and periocular procedures. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device. It carries product code HOZ and is regulated under 21 CFR 886.4790, within the Ophthalmic medical specialty.

    510(k) Clearances

    47 matches
    K Number
    Device Name
    SUNTOUCH EYE SPEAR
    NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
    ALPHAMED SURGICAL SPEAR, MODEL 70-5000
    CENEFOM PVA SURGICAL SPEAR
    ULTRACELL ABSORBENT STICK
    MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
    PRESCOTT'S SURGICAL SPEAR
    ML EYE SPEAR, MODEL ML 27 ES
    M-PACT CORNEAL LIGHT SHIELD
    DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
    SOF-SUCTION FLUID EVACUATION SYSTEM
    THE FREMSTAD RING
    HYDROFERA SURGICAL SPEAR
    ULTRACELL SUCTION SPONGE
    DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
    IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
    EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
    IVALON OPHTHALMIC SPONGE
    OPHTHALMIC SPONGES
    SURGI-WIPE
    VISI-SPEAR EYE SPONGE
    SURGICAL SPEARS
    OPHTHALMIC SPONGES
    OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
    VISI-SWAB OPHTALMIC SPONGE
    VISI-SORB ABSORBANT STICK
    K-SPONGE
    VISITEC MICRO-SPONGE SPEARS
    MICROSPEARS
    ALCON SURGICAL SPONGE
    FLUID DRAINAGE WICK
    SOLOS EYESITE SPONGES
    ASCON OPHTHALMIC SPONGE
    EYE PROCEDURE PACK
    AMPCO OPTHALMIC TRAY
    PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
    STERILE EYE SURGERY KITS
    PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
    SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
    OPERAID SURGICAL DRAIN
    EYE SPEAR
    EYE SPONGE OR SPEAR
    FLORET OPHTHALMIC EYE SPEAR
    PRO-OPHTA STICKS
    SOFT SILICONE ELASTOMER SPONGE EXPLANT
    MICROSPEARS
    CELLULOSE EYE STICK

    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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