K252528
- 510(k) number
- K252528
- Device name
- Ion Endoluminal System (IF1000)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2025-09-05
- Date received
- 2025-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252528.pdf
Official FDA record: K252528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.