K232038
- 510(k) number
- K232038
- Device name
- BioStar Single Use Transbronchial Aspiration Needle
- Applicant
- Broncus Medical, Inc. CA · US
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2024-04-26
- Date received
- 2023-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
510(k) Summary (official FDA PDF): K232038.pdf
Official FDA record: K232038
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.