K230778
- 510(k) number
- K230778
- Device name
- EndoCore
- Applicant
- Praxis Medical, LLC FL · US
- Product code
- KTI — Bronchoscope Accessory
- Decision date
- 2023-09-25
- Date received
- 2023-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230778.pdf
Official FDA record: K230778
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.