FDA 510(k), K163069, OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

FDA 510(k), K163069, OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

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510(K) Number: K163069
Device Name: OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 11/02/2016
Decision Date: 01/19/2017
Regulation Medical Specialty: Gastroenterology/Urology

Total pages: 2186
Fully redacted pages: 1191
Content pages: 995

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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