FDA 510(k) K182588, Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider, by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

FDA 510(k) K182588, Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider, by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

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Device Classification Name: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
510(k) Number: K182588
Device Name: Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Regulation Number: 878.44
Classification Product Code: NUJ
Date Received: 2018-09-20
Decision Date: 2018-10-31
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 1,783
Fully redacted pages: 1,500
Content pages: 283

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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