• FDA 510(k) records for EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL K850431
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FDA 510(k) K191177, LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head, by Smith and Nephew, Inc.

FDA 510(k) K191177, LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head, by Smith and Nephew, Inc.

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FDA 510(k) records for LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (K191177), submitted by Smith and Nephew, Inc..

  • 510(k) Number: K191177
  • Device Classification: Laparoscope, General & Plastic Surgery
  • Applicant: Smith and Nephew, Inc.
  • Date Received: 05/02/2019
  • Decision Date: 08/23/2019
  • Decision: Substantially Equivalent (SESE)
  • Regulation Number: 876.15
  • Product Code: GCJ
  • Regulation Medical Specialty: Gastroenterology/Urology
  • Review Panel: General & Plastic Surgery
  • Total Pages: 2699 (2098 unredacted, 22% redacted overall)

What's in this document (sections may appear in any order):

  • ✗ 510(k) Summary / Statement: 87% redacted
  • ✗ Indications for Use: 86% redacted
  • ✗ Device Description: 100% redacted
  • ✗ Substantial Equivalence / Predicate: 80% redacted
  • ✗ Performance / Bench Testing: 83% redacted
  • ✗ Biocompatibility: 100% redacted
  • ✗ Software / Cybersecurity: 77% redacted
  • ✗ Sterilization / Shelf Life: 80% redacted
  • ✗ Labeling / IFU: 81% redacted
  • ✗ Clinical Data: 100% redacted
  • ~ FDA Correspondence: 52% redacted
  • ✗ Risk Analysis / FMEA: 100% redacted
  • ✗ Electromagnetic Compatibility (EMC): 87% redacted

Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.

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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