K252889
- 510(k) number
- K252889
- Device name
- Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2025-11-25
- Date received
- 2025-09-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252889.pdf
Official FDA record: K252889
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.