FDA 510(k) K172856, Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider, by Stryker Sustainability Solutions

FDA 510(k) K172856, Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider, by Stryker Sustainability Solutions

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Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number: K172856
Device Name: Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider
Applicant: Stryker Sustainability Solutions
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 09/20/2017
Decision Date: 11/16/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 4,275
Fully redacted pages: 3,982
Content pages: 293

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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