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FDA 510(k)

CVAC Aspiration System

K-Number: K260965 · 2026-04-13

ApplicantCalyxo, Inc.
Decision Date2026-04-13
Product CodeFED
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 2026-04-13 under 510(k) number K260965. The device is classified under product code FED. 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 2026-04-13. The listed applicant is Calyxo, Inc.. The 510(k) number is K260965.

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

CVAC Aspiration System received FDA 510(k) clearance on 2026-04-13, under 510(k) number K260965.

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 FED.

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.

K260013CVAC Image ProcessorK233472CVAC Aspiration System + CVAC Image Processor

Related Devices (Code: FED)

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.

K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.K251599Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.

Official Source

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

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