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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K260013
Device Name CVAC Image Processor
Applicant
Calyxo, Inc.
4473 Willow Rd.
Suite 100
Pleasanton,  CA  94588
Applicant Contact Joseph Catanese
Correspondent
Calyxo, Inc.
4473 Willow Rd.
Suite 100
Pleasanton,  CA  94588
Correspondent Contact Nitya Narayanan
Regulation Number876.1500
Classification Product Code
FGB  
Date Received01/05/2026
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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