K252874
- 510(k) number
- K252874
- Device name
- Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
- Applicant
- Serpex Medical, Inc. CA · US
- Product code
- KTI — Bronchoscope Accessory
- Decision date
- 2025-10-08
- Date received
- 2025-09-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
510(k) Summary (official FDA PDF): K252874.pdf
Official FDA record: K252874
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.