FDA 510(k) K031891, VIRTUOSAPH, by Terumo Cardiovascular Systems Corp.

FDA 510(k) K031891, VIRTUOSAPH, by Terumo Cardiovascular Systems Corp.

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Device Classification Name: Laparoscope, General & Plastic Surgery
510(k) Number: K031891
Device Name: VIRTUOSAPH
Applicant: Terumo Cardiovascular Systems Corp.
Regulation Number: 876.1500
Classification Product Code: GCJ
Date Received: 06/13/2003
Decision Date: 07/29/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: General & Plastic Surgery

Total number of pages: 307
Fully redacted pages: 79
Content pages: 228

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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