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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K260177
Device Name Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)
Applicant
Xenocor, Inc.
615 Arapeen Dr.
Suite #205
Salt Lake City,  UT  84108
Applicant Contact Brandon Kessler
Correspondent
Xenocor, Inc.
615 Arapeen Dr.
Suite #205
Salt Lake City,  UT  84108
Correspondent Contact Brandon Kessler
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
GCQ   HET  
Date Received01/21/2026
Decision Date 02/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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