CVAC Aspiration System + CVAC Image Processor
FDA 510(k) clearance K233472 · decided 2024-02-02
Clearance details
- K-number
- K233472
- Device name
- CVAC Aspiration System + CVAC Image Processor
- Applicant
- Calyxo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-10-25
- Decision date
- 2024-02-02
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- FED
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic recall (Z-1396-2025) | Calyxo, Inc. | 2025-03-21 |