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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: HQE FDA class 2

    Instrument, Vitreous Aspiration And Cutting, Ac-Powered

    Ophthalmic

    View full classification →

    An AC-Powered Vitreous Aspiration and Cutting Instrument is an ophthalmic surgical device used during vitreoretinal surgery to aspirate, cut, and remove the vitreous gel from the posterior segment of the eye, enabling access to the retina for repair of retinal detachments, macular holes, and other posterior segment conditions. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQE and is regulated under 21 CFR 886.4150, within the Ophthalmic medical specialty. It is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    UniVit HE, UniVit UHS
    Cetus system, Cetus probe
    Bi-Blade Vitrectomy Cutter
    CONSTELLATION VISION SYSTEM
    VERSAVIT
    PROCARE PLUS VITRECTOMY SYSTEM
    ULTIMATE VIT ENHAMCER (UVE)
    COLIBRI DISPOSABLE VITRECTOMY CUTTER
    VMATE MODEL VMM1000
    VELOCITY ADVANTAGE
    MID LABS AUTONOMOUS VIT ENHANCER (AVE)
    D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
    VIT ENHANCER
    I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
    D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
    PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
    PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
    STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
    REUSABLE VITRECTOMY PROBE
    DISPOSABLE VITRECTOMY PROBE
    STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
    VIT COMMANDER SYSTEM
    STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
    AUTOMATED VITRECTOMY DEVICE
    STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
    STORZ MVS-3201 VITRECTOMY PROBE PACK
    STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
    CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
    PRO-VIT
    INFINITECH ASPIRATING LASER PROBE
    INFINITECH SOFT TIP FLUTE NEEDLE
    MICRODRIVE
    NIDEK MODEL VT-4000, MODIFICATION
    PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE
    VIT CUTTER MODEL 94
    SUPRA-VIT(TM)
    THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE
    STORZ FIBEROPTIC PICK MANIPULATOR
    OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
    INTERTIP INFUSION SET
    STORZ FIBEROPTIC REVERSE CUTTING KNIFE
    BARE-FIBER ENDOILLUMINATOR
    NIDEK MODEL VST-4000
    MID LABS, INC. VIT MATE
    STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
    POLLY'S VITREOUS SCISSORS J-225-S
    STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
    STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
    DISPOSABLE POSTERIOR MICROSCISSORS
    180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.

    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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