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    FDA 510(k) K221385, LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02), by Ovesco Endoscopy AG

    FDA 510(k) K221385, LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02), by Ovesco Endoscopy AG

    $833.54 USD
    $833.54 USD
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    Device Classification Name: Submucosal Injection Agent
    510(k) Number: K221385
    Device Name: LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
    Applicant: Ovesco Endoscopy AG
    Regulation Number: 876.1500
    Classification Product Code: PLL
    Date Received: 05/13/2022
    Decision Date: 08/11/2022
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Gastroenterology/Urology
    510k Review Panel: Gastroenterology/Urology

    Total number of pages: 1,917
    Fully redacted pages: 1,644
    Content pages: 273

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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