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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 K260710
Device Name FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
Applicant
FloShield, Inc.
1013 Cactus Rio Dr.
Weatherford,  TX  76087
Applicant Contact Laird Cagan
Correspondent
Advance BioReg, Inc.
4170 Bowmansroot Ct.
Hlliard,  OH  43026
Correspondent Contact Trudie Seeger
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/04/2026
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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