CVAC Aspiration System— 510(k) K260965
Substantially EquivalentCalyxo, Inc.
FDA 510(k) clearance K260965 for CVAC Aspiration System, Substantially Equivalent on 2026-04-13. Applicant: Calyxo, Inc.. Device class: 2.
Clearance details
- Applicant
- Calyxo, Inc.
- Product code
- Code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code FED
view all- K260410 — Single Use Ureteral Access Sheath
- K261915 — Navigator Flex Ureteral Access Sheath Set
- K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
- K252572 — Prodeon Urethral Sheath System
- K250128 — Single Use Suction-Evacuation Ureteral Access Sheath
More clearances from Calyxo, Inc.
view allAdverse events under product code FED
product code FED- Death
- 10
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.