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: KNS FDA class 2

    Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

    Gastroenterology, Urology

    View full classification →

    An Endoscopic Electrosurgical Unit with or without Accessories is a device used in gastroenterology and urology to cut and coagulate tissue during endoscopic procedures using high-frequency electrical energy, applied in procedures such as polypectomy, hemostasis, and transurethral resection. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNS and it is regulated under 21 CFR 876.4300 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Rezum System
    SpydrBlade Flex Instrument (PRD-RG1-001)
    SB Knife Jr2 (MD-47702 and MD-47702L)
    Disposable Sphincterotome
    Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
    Aqua Medical RF Vapor Ablation System
    Reusable Interface Cable 1.5 m (PRD-IFC-002)
    Disposable Sphincterotome
    Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
    Disposable Sphincterotome
    Speedboat Flush SB1 Instrument
    AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)
    ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
    Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
    Habib EndoHPB
    Sphincterotome
    Optimos™ Cystotome
    MCB UNIT Model: V10GMCBUS
    Cysto-Gastro-Sets
    Multi-Functional Electrosurgical Knife
    RF Vapor System
    Sphincterotome / short-wire compatible, Sterile Sphincterotome
    Aqua Medical RF Vapor System
    Sphincterotome
    ORISE ProKnife
    Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
    Creo Electrosurgical System with HS1 Hemostasis Accessory
    TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
    Single Use Balloon Dilator V (with knife)
    Rezum System
    Aqua Medical RF Vapor System
    Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
    SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
    ELRA Electrode
    Rezum Delivery Device, Rezum Generator
    Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
    Fusion OMNI Sphincterotome
    Habib EndoHPB
    Rezum System
    Barrx SB RFA Endoscopic Catheter
    Single Use Electrosurgical knife
    Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
    Zimmon Needle Knife Papillotome
    SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
    Rezum System
    Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
    Single Use Balloon Dilator V (with Knife)
    Rezum System
    SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP
    INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER

    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