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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K233472
Device Name CVAC Aspiration System + CVAC Image Processor
Applicant
Calyxo, Inc.
4473 Willow Rd.
Suite 100
Pleasanton,  CA  94588
Applicant Contact Joseph Catanese III
Correspondent
Calyxo, Inc.
4473 Willow Rd.
Suite 100
Pleasanton,  CA  94588
Correspondent Contact Diane Horwitz
Regulation Number876.1500
Classification Product Code
FED  
Subsequent Product Code
FGB  
Date Received10/25/2023
Decision Date 02/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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