K230328
- 510(k) number
- K230328
- Device name
- Speedboat Flush SB1 Instrument
- Applicant
- Creo Medical, Ltd. GB
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2023-10-31
- Date received
- 2023-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230328.pdf
Official FDA record: K230328
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.