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    FDA 510(k) K162751, Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider, by Surgical Instrument Services and Savings, Inc.

    FDA 510(k) K162751, Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider, by Surgical Instrument Services and Savings, Inc.

    $810.03 USD
    $810.03 USD
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    Device Classification Name: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
    510(k) Number: K162751
    Device Name: Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
    Applicant: Surgical Instrument Services and Savings, Inc.
    Regulation Number: 878.4400
    Classification Product Code: NUJ
    Date Received: 09/30/2016
    Decision Date: 05/01/2017
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: General & Plastic Surgery
    510k Review Panel: General & Plastic Surgery

    Total number of pages: 2,041
    Fully redacted pages: 1,779
    Content pages: 262

    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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