CVAC Aspiration System + CVAC Image Processor— 510(k) K233472

Name: FDA 510(k) clearance K233472
Creator: U.S. Food and Drug Administration
Published: 2024-02-02

Substantially Equivalent

Calyxo, Inc.

FDA 510(k) clearance K233472 for CVAC Aspiration System + CVAC Image Processor, Substantially Equivalent on 2024-02-02. 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: 2023-10-25
Decision date: 2024-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FED

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K260410 — Single Use Ureteral Access Sheath2026-09-11
K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
K260965 — CVAC Aspiration System2026-04-13
K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)2026-04-06
K252572 — Prodeon Urethral Sheath System2025-10-07

More clearances from Calyxo, Inc.

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K260013 — CVAC Image Processor2026-03-06

Adverse events under product code FED

product code FED

Death: 10
Total: 10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K233472

K-number listed on FDA's recall record

Z-1396-2025 — CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.Class I·Ongoing·Calyxo, Inc.·20250219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233472.

Data sourced from openFDA. This site is unofficial and independent of the FDA.