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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 K221365
FOIA Releasable 510(k) K221365
Device Name LapBox Tissue Containment Removal System
Applicant
Ark Surgical, Ltd.
13wadi El Hadj
Nazareth,  IL
Applicant Contact Stav Tori
Correspondent
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/12/2022
Decision Date 08/25/2022
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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