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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 K221740
Device Name SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
Applicant
Smith and Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Renesha Srivastava
Correspondent
Smith and Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Renesha Srivastava
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/15/2022
Decision Date 10/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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