CVAC® Aspiration System— 510(k) K261447
Substantially EquivalentCalyxo, Inc.
FDA 510(k) clearance K261447 for CVAC® Aspiration System, Substantially Equivalent on 2026-09-15. Applicant: Calyxo, Inc.. Device class: 2.
Summary
Calyxo, Inc. submitted the CVAC Aspiration System under product code FGB (Ureteroscope And Accessories, Flexible/Rigid). The record has nothing on the system beyond its name and code.
Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Calyxo filed from Pleasanton, California. The decision came 137 calendar days after receipt (May 1 to September 15, 2026).
Clearance details
- Applicant
- Calyxo, Inc.
- Product code
- Product code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code FGB
view all- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
- K253505 — Zamenix P
- K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
More clearances from Calyxo, Inc.
view allAdverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
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.