LapBox Tissue Containment Removal System

Laparoscope, General & Plastic Surgery

ARK Surgical, Ltd.

The following data is part of a premarket notification filed by Ark Surgical, Ltd. with the FDA for Lapbox Tissue Containment Removal System.

Pre-market Notification Details

Device IDK221365
510k NumberK221365
Device Name:LapBox Tissue Containment Removal System
ClassificationLaparoscope, General & Plastic Surgery
Applicant ARK Surgical, Ltd. 13 Wadi El Hadj Nazareth,  IL
ContactStav Tori
CorrespondentBosmat Friedman
ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte,  NC  28269
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-12
Decision Date2022-08-25

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