FDA 510(k) K241168, System 83 Revolve Endoscope Washer/Disinfector, by Wassenburg Medical, Inc.

FDA 510(k) K241168, System 83 Revolve Endoscope Washer/Disinfector, by Wassenburg Medical, Inc.

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Device Classification Name: Accessories, Cleaning, For Endoscope
510(k) Number: K241168
Device Name: System 83 Revolve Endoscope Washer/Disinfector
Applicant: Wassenburg Medical, Inc.
Regulation Number: 876.15
Classification Product Code: FEB
Date Received: 2024-04-26
Decision Date: 2024-12-19
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: General Hospital

Total number of pages: 5,773
Fully redacted pages: 4,931
Content pages: 842

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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