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FDA 510(k)

CVAC® Aspiration System

K-Number: K261447 · 2026-09-15

ApplicantCalyxo, Inc.
Decision Date2026-09-15
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CVAC® Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Calyxo, Inc.. It received FDA 510(k) clearance on 2026-09-15 under 510(k) number K261447. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVAC® Aspiration System?

CVAC® Aspiration System is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Calyxo, Inc.. The 510(k) number is K261447.

When did CVAC® Aspiration System receive FDA 510(k) clearance?

CVAC® Aspiration System received FDA 510(k) clearance on 2026-09-15, under 510(k) number K261447.

Who is the listed applicant for CVAC® Aspiration System?

The FDA 510(k) record lists Calyxo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CVAC® Aspiration System?

The FDA product code for CVAC® Aspiration System is FGB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07101809Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration TechnologyRECRUITING

Other records listing Calyxo, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260965CVAC Aspiration SystemK260013CVAC Image ProcessorK233472CVAC Aspiration System + CVAC Image Processor

Related Devices (Code: FGB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific CorporationK262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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