K241168
- 510(k) number
- K241168
- Device name
- System 83 Revolve Endoscope Washer/Disinfector
- Applicant
- Wassenburg Medical, Inc. PA · US
- Product code
- FEB — Accessories, Cleaning, For Endoscope
- Decision date
- 2024-12-19
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241168.pdf
Official FDA record: K241168
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.