K260965
- 510(k) number
- K260965
- Device name
- CVAC Aspiration System
- Applicant
- Calyxo, Inc. CA · US
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2026-04-13
- Date received
- 2026-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K260965.pdf
Official FDA record: K260965
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.