K251664
- 510(k) number
- K251664
- Device name
- Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- KTI — Bronchoscope Accessory
- Decision date
- 2025-07-29
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251664.pdf
Official FDA record: K251664
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.