K232984
- 510(k) number
- K232984
- Device name
- Ion Endoluminal System (IF1000)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2023-12-18
- Date received
- 2023-09-22
- 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: K232984.pdf
Official FDA record: K232984
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.