FDA 510(K) K100442, FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

FDA 510(K) K100442, FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

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Device Classification Name    Laparoscope, General & Plastic Surgery
510(k) Number    K100442
Device Name    FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
Applicant    SURGICAL INNOVATIONS GROUP PLC
Regulation Number    876.1500
Classification Product Code    GCJ  
Date Received    02/17/2010
Decision Date    09/07/2010
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Gastroenterology/Urology
510k Review Panel    General & Plastic Surgery

Total pages: 343  
Fully redacted pages: 166  
Content pages: 177 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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