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: GES FDA class 1

    Blade, Scalpel

    General, Plastic Surgery

    View full classification →

    The Scalpel Blade (product code GES) is a sterile, single-use or reusable surgical cutting instrument used universally in general and plastic surgery for making precise incisions in tissue. It is classified as an FDA Class 1 device, the lowest risk category, governed only by general controls and not requiring premarket notification. Regulated under 21 CFR 878.4800 and assigned to the General, Plastic Surgery specialty (SU), this device carries no special regulatory flags.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    PERSONNA PLUS SAFETY SCALPEL SYSTEM
    EASY-ON
    LOS ALAMOS RETRACTABLE KNIFE
    SCALPEL BLADE REMOVER (BLADEGARD)
    PRECISION GLIDE - ENHANCED SURGICAL BLADE
    STERILE CARBON STEEL SURGICAL BLADE
    ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
    SURGICAL BLADE
    SURGICAL BLADES
    NINJA SCALPEL
    PERSONNA DISPOSABLE SCALPEL
    SABLE BLADES
    DEXTRA DISPOSABLE BLADES
    KEISEI MICRO-BLADES (STERILE AND NON-STERILE)
    KEISEI SURGICAL BLADES (STERILE & NON-STERILE)
    ANGIOMED SKIN FASCIA KNIFE
    BLADES, SCALPEL CARBON STEET
    BLADES, SCALPEL STAINLESS STEEL
    SURGICAL BLADES
    BLADE, SCALPEL
    STAINLESS STEEL & CARBON STEEL STERILE BLADES
    APOLLO STERILE BLADES
    STERILE SURGICAL BLADES
    SURGIMED - SURGICAL BLADES
    SURGICAL SCALPEL BLADES & DISPOSABLES
    LANCE BLADES & SCALPELS
    SURGEON'S BLADES STERILE BLADE
    PERCUTANEOUS TRIG. FINGER RELEASE KNIFE
    FASCIA CUTTER
    JAKOBI SURG. INSTRUMENTS #1 19/10/26
    JAKOBI SURG. INSTRUMENTS #11 11/13/14
    H.R. JAKOBI SURG. INSTRUMENTS #11 27/37
    DISP. MICROSURGICAL KNIVES
    SURGICAL BLADES & SCAPELS (SMPL. W/510K)
    MICRO BLADE II
    MICROSURGICAL BLADE
    RK IV SURGICAL BLADES
    BLADE, HANDLE, SCALPEL FORCEPS, SURGERY
    BLADE, 20 ANGLE/MICRO BLADE HOLDER
    BLADES, SCALPEL
    HANDLES, BLADE, SURGICAL
    BLADES, SURGICAL, STERILE
    LANCE LTD. STERI. STITCH CUTTER BLADE
    SURGICAL BLADES
    LIGHTCAST II CARBIDE BLADE
    HANDLE, SCALPEL, STAINLESS STEEL
    SCALPEL, SURGICAL, STERILE STAINLESS
    BLADE, SURGICAL SCALPEL, STERILE

    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