CVAC Image Processor

FDA 510(k) K260013 · Calyxo, Inc.

Substantially Equivalent

510(k) numberK260013

Submission

Device name
CVAC Image Processor
Applicant
Calyxo, Inc.
Pleasanton, CA, US
Received
January 5, 2026
Decision date
March 6, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FGB – Ureteroscope And Accessories, Flexible/Rigid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code FGB

510(k)DeviceApplicantDecision
K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…FGB · Traditional Guangzhou Red Pine Medical Instrument Co., Ltd.09/09/2026SE
K261153LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional Boston Scientific Corporation08/26/2026SE
K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special Scivita Medical Technology Co., Ltd.08/14/2026SE
K253505Zamenix™ PFGB · Traditional Roen Surgical, Inc.08/07/2026SE
K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR…FGB · Traditional MacroLux Medical Technology Co., Ltd.07/20/2026SE
K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…FGB · Traditional Anhui Happiness Workshop Instruments Co., Ltd.04/09/2026SE
K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…FGB · Traditional Zhejiang Geyi Medical Instrument Co., Ltd.12/16/2025SE
K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…FGB · Traditional Guangzhou Red Pine Medical Instrument Co., Ltd.12/16/2025SE
K253411Miniature Telescope for Urology (27033AA)FGB · Traditional Karl Storz SE & CO. KG11/18/2025SE
K250917Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model:…FGB · Traditional Shenzhen Sanping Image Technology Co., Ltd.10/31/2025SE

More from Shenzhen Sanping Image Technology Co., Ltd.

510(k)DeviceDecision
K260965CVAC Aspiration SystemFED · Special 04/13/2026SE
K233472CVAC Aspiration System + CVAC Image ProcessorFED · Traditional 02/02/2024SE

Questions and answers

When was CVAC Image Processor cleared by the FDA?

CVAC Image Processor (K260013) received a 510(k) decision of Substantially Equivalent on March 6, 2026, 60 days after the submission was received.

What is the product code of K260013?

The FDA product code is FGB – Ureteroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.