FDA 510(k) K141558, QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, by Surgical Specialties Corp

FDA 510(k) K141558, QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, by Surgical Specialties Corp

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Device Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number: K141558
Device Name: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
Applicant: Surgical Specialties Corp
Regulation Number: 878.4493
Classification Product Code: GAM
Date Received: 2014-06-12
Decision Date: 2014-07-11
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 294
Fully redacted pages: 158
Content pages: 136

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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