Pleasanton, CA, US · 4 510(k) clearances · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 2 | 2026-09-15 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 2 | 2026-04-13 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-02-19 | Class I | Ongoing | Z-1396-2025 | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urina… | — | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patien… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-15 | K261447 | CVAC® Aspiration System | FGB | Class II | Gastroenterology, Urology |
| 2026-04-13 | K260965 | CVAC Aspiration System | FED | Class II | Gastroenterology, Urology |
| 2026-03-06 | K260013 | CVAC Image Processor | FGB | Class II | Gastroenterology, Urology |
| 2024-02-02 | K233472 | CVAC Aspiration System + CVAC Image Processor | FED | Class II | Gastroenterology, Urology |