BEUDAMED
    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: EFQ FDA unclassified

    Gauze/Sponge, Internal

    Unknown

    View full classification →

    The Internal Gauze/Sponge is a device used within body cavities or surgical sites to absorb fluids, maintain hemostasis, or protect underlying tissues during surgical procedures. It has not been formally classified by the FDA (unclassified status) and no regulation number has been assigned. The product code is EFQ, and regulatory status for this device type remains pending final classification action.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
    SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
    VITOP DRESSING
    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
    CROSSTEX NON-WOVEN SPONGES
    GAUZE, SPONGES, CAT # 11-003
    DYNAREX TRACHEOSTOMY SPONGE
    STARRYSHINE GAUZE SPONGE
    JOAN II
    DUMEX PAK-ITS WOVEN RIBBON PACKING
    HYDROFERA FEMORAL WICK
    BALDUR NON-STERILE COTTON SPONGES
    KENDALL CURITY IODOFORM PACKING STRIP
    INVOTEC CLEAN PAD
    PIN CARE KIT
    OPPORTUNITY SUTURE REMOVAL KIT
    OPPORTUNITY INCISION AND DRAINAGE TRAY
    RAND SURGICAL SPONGE
    PRIMED PRIME-PLUS COTTON GAUZE SPONGES
    DUKAL NON ADHERENT DRESSING
    DUKAL ABD COMBINE PAD
    SIMAR, INC. SURGICAL DRESSING
    GAUZE SPONGE, NON X-RAY DETECTABLE
    GAUZE COMPRESS
    DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
    SURGICADE GAUZE SPONGE
    DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
    PRO-FECT STERILE GAUZE SPONGES
    PROTEC STERILE GAUZE SPONGE
    PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
    STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)
    CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
    EMERALD STERILE GAUZE SPONGE
    NHMC DRESSING TRAY
    DYNAREX NON-WOVEN SPONGE
    PROTEC ROLL GAUZE
    GENERAL USE SYNTHETIC SPONGE (STERILE)
    SYNTHETIC SPONGE
    PROTEC GAUZE SPONGE
    KENTEX
    FLUFF GAUZE BANDAGE, STERILE & NON-STERILE
    MEROCEL VAGINAL PACK
    ADI STERILE GAUZE SPONGES
    LESINSKI SURGICAL EAR DRESSING
    HEMO-BARRIER TOURNIQUET
    DYNAREX GAUZE SPONGE
    LOCKETT MEDICAL CORP. GAUZE
    LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE
    GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)
    1X6YD, 2X6YD, 4X6YD ROLL BANDAGE

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump