K233472
- 510(k) number
- K233472
- Device name
- CVAC Aspiration System + CVAC Image Processor
- Applicant
- Calyxo, Inc. CA · US
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2024-02-02
- Date received
- 2023-10-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K233472.pdf
Official FDA record: K233472
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.