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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 K242606
Device Name Nuvis® Wireless HD Camera System (Nuvis-2K)
Applicant
Integrated Endoscopy, Inc.
16 Technology Dr. Suite 165
Irvine,  CA  92618
Applicant Contact Albert Rego
Correspondent
Integrated Endoscopy, Inc.
16 Technology Dr. Suite 165
Irvine,  CA  92618
Correspondent Contact Albert Rego
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/30/2024
Decision Date 11/20/2025
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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