510(k) K233472 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
CVAC Aspiration System + CVAC Image Processor
| Applicant | Calyxo, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Feb 2, 2024 |
| Received | Oct 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2025 | Calyxo, Inc. CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior. Open, Classified |
FED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.