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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 K263459
Device Name SWICS™
Applicant
Bloom Surgical, Inc.
15 Mario Capecchi Dr.
Salt Lake City,  UT  84108
Applicant Contact Jacob Sheffield
Correspondent
Quaras, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/28/2026
Decision Date 10/29/2026
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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