LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251743
    Device Name
    SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
    Manufacturer
    Surgical Principals, Inc.
    Date Cleared
    2025-09-22

    (108 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K111845
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LaproSac™ Specimen Retrieval Bags is indicated for use in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery.

    Device Description

    The SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval Systems are sterile single patient use devices, which comprise of a flexible nylon bag with and without a deployment mechanism. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists for an introducer and actuation rod with biasing arms, which allows for insertion through an appropriately sized port and automatic opening of the bag upon deployment.

    These devices are not made with natural rubber latex or synthetic derivatives of natural rubber latex.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1