510(k) clearance
CVAC® Aspiration System
- 510(k) number
- K261447
- Applicant
- Calyxo, Inc.
- Decision date
- Sep 15, 2026
- Date received
- May 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FGB
- Device type
- Ureteroscope And Accessories, Flexible/Rigid
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Pleasanton, CA, US