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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: FED FDA class 2

    Endoscopic Access Overtube, Gastroenterology-Urology

    Gastroenterology, Urology

    View full classification →

    The Endoscopic Access Overtube for Gastroenterology-Urology (product code FED) is a tubular sleeve placed over an endoscope to facilitate its passage and advancement into the body, particularly useful in cases requiring repeated intubation or difficult access. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Single-use Ureteral Access Sheath
    Single-use Ureteral Access Sheath
    LumenaTM Ureteral Access Sheath
    CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
    Disposable ureteral access sheath
    Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
    Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
    Ureteral Access Sheath
    Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
    Over-tube (TR-1108A)
    Single-use Ureteral Access Sheath
    Disposable Ureteral Guide Sheath
    Pathfinder® CR System
    CVAC Aspiration System + CVAC Image Processor
    Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
    Disposable Ureteral Access Sheath
    Pathfinder Endoscope Overtube with Balloon Device
    Single Use Ureteral Access Sheath
    Mini PCNL-System
    Pathfinder Endoscope Overtube
    Disposable Ureteral Access Sheath
    ClearPetra Suction-Evacuation Sheath
    Dornier MAGELLAN Ureteral Access Sheath
    Kalera Vacuum Aspiration Catheter (K-VAC)
    PatCom Single-Use Introducer
    Pathfinder Endoscope Overtube
    Arc Endocuff Glide AEG110 & AEG120
    Peel-Away Introducer
    Flexible Overtube
    Embrella Endoscopic Distal Attachment
    ReTrace Ureteral Access Sheath
    ORISE Tissue Retractor System
    Trans-anal Introducer
    BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
    Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
    Arc EndoCuff and Arc EndoCuff Vision
    ClearPetra Suction-Evacuation Sheath
    AmplifEYE
    Proxis Ureteral Access Sheath
    Well Lead Ureteral Access Sheath
    Arc Endocuff Vision
    Sidecar External Working Channel
    RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
    NAVIGATOR HD URETERAL ACCESS SHEATH SETS
    ANAL RECTAL OVERTUBE
    ENDORINGS
    ENDOSCOPIC INTRODUCER
    RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
    NAVIGATOR HD URETERAL ACCESS SHEATH SET
    OVERTUBE ENDOSCOPIC ACCESS SYSTEM

    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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