BEUDAMED
    Product Code: OTJ FDA class 2 21 CFR 876.1500

    Laparoscopic Single Port Access Device

    Gastroenterology, Urology

    The Laparoscopic Single Port Access Device (product code OTJ) is a surgical access device that provides a single entry point through which multiple instruments and/or a camera can be introduced during minimally invasive abdominal laparoscopic surgery. It enables surgeons to perform complex laparoscopic procedures through a single incision rather than multiple trocar sites. As an FDA Class 2 device under regulation 876.1500, it requires 510(k) premarket clearance and falls within the Gastroenterology and Urology specialty, reviewed by the Surgery panel. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    11
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    8
    Years Active
    13

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    Basic Information

    Product Code
    OTJ
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K232062 Uni-port
    K220081 CORE-SPORT
    K202688 AFS Medical Sterile Single-Use Access Port System
    K160797 FMX314 Surgical Platform
    K152598 Endo Keeper
    K121309 ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
    K120898 KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
    K111407 TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
    K112196 OCTOTMPORT
    K110004 ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
    K101794 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.