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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 K260185
Device Name 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
Applicant
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Divya Sekar
Correspondent
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact Divya Sekar
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
GWG   NWB  
Date Received01/21/2026
Decision Date 02/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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