K262792
- 510(k) number
- K262792
- Device name
- Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
- Applicant
- Hologic, Inc. MA · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2026-08-12
- Date received
- 2026-08-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K262792.pdf
Official FDA record: K262792
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.