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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: GCJ FDA class 2

    Laparoscope, General & Plastic Surgery

    Gastroenterology, Urology

    View full classification →

    The Laparoscope, General and Plastic Surgery (product code GCJ) is a rigid or flexible endoscope introduced into the abdominal cavity through a small incision to provide visualization during minimally invasive surgical procedures, including diagnostic inspection, biopsy, and laparoscopic operations. It is classified as FDA Class 2, requiring a 510(k) premarket notification. Reusable versions must include validated reprocessing instructions and reprocessing validation data in the 510(k) submission for specific design features, as detailed in 82 FR 26807. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU).

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Disposable Trocars
    8 mm Assist Cannula; 12 mm Assist Cannula
    Boehringer Laboratories Liver Retractor
    Medical Monitor (32HS710S)
    Arthrex Synergy Vision Endoscopic Imaging System
    LAGIS Suction Irrigation System
    DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
    Medical Monitor (27HS714S)
    Arthrex NanoScope System
    LCD Monitor (MDEC-2523)
    Suction Irrigation Tubing Set
    MultiCut Solo
    LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
    FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
    Bladeless Trocar; Bladed Trocar; Hasson Trocar
    TroCare TroKit Laparoscope Lens Wiper (CP000626)
    da Vinci Handheld Camera
    Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
    Medical Monitor (32HR734S)
    Stellar Imaging System
    Universal Seal (5-12 mm)
    Arthrex Synergy Vision Endoscopic Imaging System
    P-SCOPE
    Endoscopic Applicator, 41 cm
    AMT Suture Passer
    Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)
    SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
    Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
    3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
    Monik™ - Disposable Endoscopic Trocar
    Ez Catch Auto; Ez Catch YR; Ez Catch TR
    Disposable Trocars
    ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm
    1688 4K Camera System with Advanced Imaging Modality
    Arthrex Synergy Vision Endoscopic Imaging System
    MD Mattress Suture Placement Device
    1788 4K Camera System with Advanced Imaging Modality
    ENDOCOLLECT Specimen Retrieval Bag
    CuratOR EX3242-FD
    Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
    Inzii Ripstop Redeployable Retrieval System
    NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);
    Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
    Guardenia (GAR-1)
    REGER Nebulizer Irrigation Cannula
    Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
    Bladeless Trocar – Artemis Lap Cannula
    Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
    Universal Seal (5-12 mm)
    KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-

    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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