K250351
- 510(k) number
- K250351
- Device name
- Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2025-10-10
- Date received
- 2025-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250351.pdf
Official FDA record: K250351
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.